FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K034051 |
3D LINE USA, INC. |
DYNATRAC, COD. 50-1A |
04/05/2004 |
K031631 |
3D LINE USA, INC. |
STEREOTACTIC BODY FRAME, MODEL COD. 70-1A |
07/18/2003 |
K212794 |
Accuray Incorporated |
Accuray Precision Treatment Planning System |
09/30/2021 |
K171086 |
Accuray Incorporated |
Accuray Precision Treatment Planning System |
06/08/2017 |
K202412 |
Accuray Incorporated |
ClearRT Helical kVCT for the Radixact Treatment Delivery System |
12/18/2020 |
K150873 |
ACCURAY INCORPORATED |
CyberKnife M6 FI Sytem, CyberKnife M6 FM System, CyberKnife M6 FIM System |
07/01/2015 |
K072504 |
ACCURAY INCORPORATED |
CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM |
09/21/2007 |
K102650 |
ACCURAY INCORPORATED |
CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM |
11/17/2010 |
K122137 |
ACCURAY INCORPORATED |
CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM CYBERKNIFE VSI ROBOTIC RADIOSURGERY SYSTEM |
10/26/2012 |
K161144 |
ACCURAY INCORPORATED |
iDMS Data Management System |
06/24/2016 |
K071531 |
ACCURAY INCORPORATED |
MODIFICATION TO CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM |
08/22/2007 |
K182687 |
ACCURAY INCORPORATED |
Motion Tracking and Compensation Feature for the Radixact Treatment Delivery System |
11/23/2018 |
K161146 |
ACCURAY INCORPORATED |
Radixact Treatment Delivery System |
06/24/2016 |
K223159 |
Accuray Incorporated |
Radixact Treatment Delivery System |
06/23/2023 |
K120233 |
ACCURAY INCORPORATED |
SYNCHRONY RESPIRATORY TRACKING SYSTEM |
03/09/2012 |
K171837 |
Accuray Incorporated |
TomoTherapy Treatment Delivery System with iDMS |
07/25/2017 |
K121934 |
ACCURAY INCORPORATED |
TOMOTHERAPY TREATMENT SYSTEM |
08/29/2012 |
K170788 |
Accuray Incorportaed |
CyberKnife Treatment Delivery System |
04/11/2017 |
K091999 |
ACCURAY, INC. |
CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM |
09/18/2009 |
K011024 |
ACCURAY, INC. |
CYBERKNIFE SYSTEM |
08/10/2001 |
K041315 |
ACCURAY, INC. |
CYBERKNIFE SYSTEM FOR STEREOTACTIC RADIOSURGERY/RADIOTHERAPY |
06/10/2004 |
K020294 |
ACCURAY, INC. |
MOTION TRACKING |
04/22/2002 |
K143560 |
Accuthera Inc. |
CygneX I System |
10/05/2015 |
K951581 |
ADAC LABORATORIES |
PINNACLE3 APEX |
04/08/1996 |
K972816 |
ADVANCED RADIATION THERAPY SYSTEMS, INC. |
ADVANCED TREATMENT PLANNING SYSTEM |
01/23/1998 |
K131313 |
AKTINA MEDICAL CORP. |
ACTIVE BREATHING COORDINATOR |
08/07/2013 |
K151097 |
AKTINA MEDICAL CORPORATION |
Active Breathing Coordinator |
05/15/2015 |
K161984 |
AKTINA MEDICAL CORPORATION |
Interlocked Circular Small Field Collimators, Elekta Integrated |
09/27/2016 |
K192102 |
Aktina Medical Corporation |
Thermoplastic Masks |
09/25/2019 |
K003330 |
AKTINA MEDICAL PHYSICS CORP. |
AKTINA MEDICAL PHYSICS CORPORATION ACTIVE BREATHING COORDINATOR (ABC) |
01/04/2001 |
K991546 |
AKTINA MEDICAL PHYSICS CORP. |
AKTINA MEDICAL PHYSICS CORPORATION TILT BOARD |
07/30/1999 |
K014081 |
AKTINA MEDICAL PHYSICS CORP. |
AKTINA MEDICAL PHYSICS RADIATION THERAPY WEDGES |
03/05/2002 |
K990997 |
AKTINA MEDICAL PHYSICS CORP. |
AKTINA MEDICALPHYSICS CORPORATION MECHANICAL FRONTPOINTER |
06/22/1999 |
K964840 |
AKTINA MEDICAL PHYSICS CORP. |
BEAM BLOCK TRAYS |
02/11/1997 |
K103616 |
AKTINA MEDICAL PHYSICS CORP. |
PINPOINT STEREOTACTIC HEAD AND NECK LOCALIZER |
01/25/2011 |
K032248 |
AKTINA MEDICAL PHYSICS CORP. |
PRECISE CARBON FIBER TABLE TOP, MODEL 11-999 |
09/25/2003 |
K040709 |
AKTINA MEDICAL PHYSICS CORP. |
PROTOS SOFTWARE |
04/28/2004 |
K081935 |
AKTINA MEDICAL PHYSICS CORP. |
STEREOTACTIC HEAD AND NECK LOCALIZER, MODEL 50-100 |
10/07/2008 |
K970384 |
AKTINA MEDICAL PHYSICS CORP. |
VELOS CONSTANCY CHECK DEVICE, MODEL 55-145 |
07/29/1997 |
K004015 |
ARPLAY MEDICAL S.A. |
BEAM BLOCK TRAYS |
03/13/2001 |
K003778 |
ARPLAY MEDICAL S.A. |
BREAST-BOARD (MULTIPLE) |
06/08/2001 |
K010063 |
ARPLAY MEDICAL S.A. |
COUCH FOR TOTAL BODY RADIATION |
04/02/2001 |
K010065 |
ARPLAY MEDICAL S.A. |
CRANIAL STEREOTACTIC EQUIPMENT |
07/02/2002 |
K003779 |
ARPLAY MEDICAL S.A. |
IMMOBILIZATION SYSTEM FOR ENT |
07/12/2001 |
K004023 |
ARPLAY MEDICAL S.A. |
INTRA OPERATIVE RADIATION THERAPY |
09/21/2001 |
K010062 |
ARPLAY MEDICAL S.A. |
STYROFOAM CUTTERS FOR BLOCK CASTING SYSTEM |
03/13/2001 |
K010174 |
ARPLAY MEDICAL S.A. |
TRAY ADAPTERS, MULTIPLE |
04/18/2001 |
K152994 |
Aurora Technology Development, LLC |
Adaptivo |
02/03/2016 |
K092285 |
BEST MEDICAL CANADA LTD. |
PORTABLE DOSIMETER DOSE VERIFICATION SYSTEM, MODEL TD-RD-90 |
08/28/2009 |
K170345 |
Best Nomos |
SOFTDISO |
10/27/2017 |
K121284 |
BFFL CO. INC |
CHABNER XRT GARMENTS |
06/14/2013 |
K120335 |
BIONIX DEVELOPMENT CORP. |
EMBRACE THERMOPLASTIC |
05/03/2012 |
K100691 |
BIONIX DEVELOPMENT CORP. |
OMNI V SBRT POSITIONING SYSTEM, MODEL RT-4500 |
05/11/2010 |
K040773 |
BIONIX DEVELOPMENT CORP. |
PELVIS BELLYBOARD PLUS PATIENT POSITIONING SYSTEM |
04/09/2004 |
K100264 |
BIONIX DEVELOPMENT CORP. |
T-FORM EXTREMITY IMMOBILIZER, MODEL RT-6060 |
04/09/2010 |
K050701 |
BIONIX DEVELOPMENT CORP. |
THIGH AND FOOT POSITIONER, SUPRONE PLUS, MODEL RT-6010 |
04/01/2005 |
K153270 |
BIONIX DEVELOPMENT CORP. |
TruGuard Custom Tongue and Jaw Positioner |
03/08/2016 |
K030051 |
BIONIX DEVELOPMENT CORP. |
VERSABOARD, MODEL 7040 |
04/04/2003 |
K173251 |
Boston Scientific Corporation |
LumiCoil Platinum Fiducial Marker |
12/19/2017 |
K202050 |
Brainlab AG |
Cranial 4Pi Immobilization |
08/19/2020 |
K072046 |
BRAINLAB AG |
EXACTRAC 3RD PARTY, EXACTRAC X-RAY 6D 3RD PARTY, EXACTRAC OEM |
10/17/2007 |
K040585 |
BRAINLAB AG |
EXACTRAC 4.0 AND EXACTRAC X-RAY 6D |
05/11/2004 |
K072506 |
BRAINLAB AG |
EXACTRAC 5.5 |
10/26/2007 |
K201276 |
Brainlab AG |
ExacTrac Dynamic |
07/13/2020 |
K203173 |
Brainlab AG |
ExacTrac Dynamic |
11/12/2020 |
K211939 |
Brainlab AG |
ExacTrac Dynamic |
07/22/2021 |
K220338 |
Brainlab AG |
ExacTrac Dynamic |
04/29/2022 |
K231052 |
Brainlab AG |
ExacTrac Dynamic 1.1.2 |
05/11/2023 |
K033287 |
BRAINLAB AG |
EXACTRAC GATING |
12/19/2003 |
K122451 |
BRAINLAB AG |
EXACTRAC VERO |
09/28/2012 |
K120789 |
BRAINLAB AG |
EXACTRAC X-RAY X-RAY |
08/14/2012 |
K053500 |
BRAINLAB AG |
FRAMELESS RADIOSURGERY COMPONENTS |
02/03/2006 |
K052220 |
BRAINLAB AG |
IPLAN RT FIBERTRACKING |
09/30/2005 |
K020860 |
BRAINLAB AG |
M3 (MICRO-MULTILEAF COLLIMATOR) |
06/06/2002 |
K004022 |
BRAINLAB AG |
M3 (MIRCO-MULTILEAF COLLIMATOR |
03/26/2002 |
K073018 |
BRAINLAB AG |
STEREOTACTIC TARGET POSITIONER, TARGET POSITIONER FOR LEKSELL HEADRING, STEREOTACTIC COUNTERWEIGHT |
01/23/2008 |
K954861 |
BRAINLAB MED. COMPUTERSYSTEME GMBH |
BRAINLAB CT/X-RAY LOCALIZER |
08/05/1996 |
K970586 |
BRAINLAB MED. COMPUTERSYSTEME GMBH |
BRAINLAB MICRO MULTI-LEAF COLLIMATOR |
05/12/1997 |
K971367 |
BRAINLAB, AG |
BRAINSCAN CONFORMAL RT MODULE |
10/27/1997 |
K003285 |
BRAINLAB, AG |
EXAC TRAC 2.0 (NOVALIS BODY MODULE) |
07/31/2001 |
K113276 |
C-RAD POSITIONING AB |
CATALYST |
02/27/2012 |
K200435 |
C-Rad Positioning AB |
Catalyst+, Catalyst+ HD |
05/07/2020 |
K063839 |
C-RAD POSITIONING AB |
POSITIONER |
02/08/2007 |
K120668 |
C-RAD POSITIONING AB |
SENTINEL |
07/30/2012 |
K200600 |
C-Rad Positioning AB |
Sentinel |
04/20/2020 |
K082582 |
C-RAD POSITIONING AB |
SENTINEL, MODEL SP-001 |
03/30/2009 |
K170058 |
Cablon Medical B.V. |
TheraView TBI |
03/03/2017 |
K080726 |
CALYPSO MEDICAL TECHNOLOGIES INC |
CALYPSO 4D LOCALIZATION SYSTEM |
05/14/2008 |
K060906 |
CALYPSO MEDICAL TECHNOLOGIES INC |
CALYPSO 4D LOCALIZATION SYSTEM |
07/28/2006 |
K112841 |
CALYPSO MEDICAL TECHNOLOGIES INC |
SURFACE BEACON TRANSPONDERS |
02/16/2012 |
K030175 |
CAPINTEC, INC. |
2 BASIC |
04/17/2003 |
K980402 |
CAPINTEC, INC. |
CAPINTEC MODEL 292 ELECTROMETER |
04/24/1998 |
K191797 |
Carbon Medical Technologies |
BiomarC Fiducial Marker |
07/29/2019 |
K211590 |
Carbon Medical Technologies Inc. |
Fiducial Marker |
06/10/2021 |
K132064 |
CARBON MEDICAL TECHNOLOGIES, INC. |
BIOMARC FIDUCIAL MARKER |
02/28/2014 |
K110772 |
CARBON MEDICAL TECHNOLOGIES, INC. |
BIOMARC FIDUCIAL MARKER |
04/28/2011 |
K130678 |
CARBON MEDICAL TECHNOLOGIES, INC. |
BIOMARC GOLD FIDUCIAL MARKER |
04/12/2013 |
K213137 |
Carina Medical LLC |
INTDose |
05/13/2022 |
K122888 |
CDR SYSTEMS, INC. |
CDR SYSTEMS PRECISION PATIENT POSITIONING SYSTEM |
04/30/2013 |
K980826 |
CII MASTEK, INC. |
EQUIDOSE SOLID STATE DIODE DETECTORS |
06/01/1998 |
K071614 |
CIVCO |
FIDUCIAL MARKERS |
09/11/2007 |
K080072 |
CIVCO MEDICAL INSTRUMENTS CO., INC. |
MRI PATIENT POSITIONING DEVICES |
06/04/2008 |
K173848 |
CNMC Co., Inc. |
Model WP-3840 and WP-3040 |
08/07/2018 |
K150265 |
CNMC COMPANY INCORPORATED |
Model 206 Electrometer/Dosimeter |
09/03/2015 |
K981535 |
COMPUTERIZED MEDICAL SYSTEMS, INC. |
FOCUS PILOT CONTOURING WORKSTATION |
04/02/1999 |
K973936 |
COMPUTERIZED MEDICAL SYSTEMS, INC. |
FOCUS RTP SYSTEM |
06/01/1998 |
K032100 |
COMPUTERIZED MEDICAL SYSTEMS, INC. |
I-BEAM |
10/02/2003 |
K032762 |
COMPUTERIZED MEDICAL SYSTEMS, INC. |
XIO RADIATION TREATMENT PLANNING SYSTEM |
12/02/2003 |
K142294 |
CORTEX MANUFACTURING, INC. |
FlexiMarc Marker |
03/26/2015 |
K100267 |
CORTEX MANUFACTURING, INC. |
FLEXIMARC, MODEL CM-0.9-2-10-GG-L |
02/24/2010 |
K101131 |
COSMAN MEDICAL, INC. |
FIDUCIAL MARKERS |
06/17/2010 |
K050888 |
DIACOR, INC. |
INTEGRA IMMOBILIZATION SYSTEM |
05/23/2005 |
K043409 |
DIREX SYSTEMS CORP. |
ACCUCHANGER |
05/05/2005 |
K021338 |
DIREX SYSTEMS CORP. |
ACCULEAF |
01/07/2003 |
K032171 |
DIREX SYSTEMS CORP. |
ACCUSOFT |
12/15/2003 |
K052705 |
DIREX SYSTEMS CORP. |
DART-12 |
02/21/2006 |
K061713 |
DIREX SYSTEMS CORP. |
MAGIS1;MAGIS2 |
07/21/2006 |
K052212 |
DIREX SYSTEMS CORP. |
MIGUE |
03/10/2006 |
K102765 |
DIREX SYSTEMS CORP. |
PRONEX |
12/07/2010 |
K071701 |
DIREX SYSTEMS CORP. |
TRACKLEAF-10 |
07/23/2007 |
K072529 |
DIREX SYSTEMS CORP. |
TRACKPORT |
10/26/2007 |
K200940 |
DoseOptics LLC |
BeamSite |
12/11/2020 |
K212606 |
DoseOptics LLC |
BeamSite |
09/15/2021 |
K191944 |
DOSIsoft |
MU2net |
10/24/2019 |
K180106 |
DOSIsoft |
ThinkQA |
03/13/2018 |
K002608 |
DUNCAN HYND ASSOCIATES, LTD. |
INVAC |
11/16/2000 |
K981911 |
DUNCAN HYND ASSOCIATES, LTD. |
PROFA |
11/12/1998 |
K092479 |
DYN'R |
SDX-SPIRODYNR'X RADIOTHERAPY BREATHING CONTROL |
01/11/2010 |
K121845 |
DYN'R SAS |
SDX SYSTEM |
10/19/2012 |
K960834 |
EASTMAN KODAK COMPANY |
KODAK EC-L CASSETTE |
05/28/1996 |
K182138 |
Eleckta Limited |
Precise Treatment System; Synergy platform; Synergy; Infinity; VersaHD |
09/05/2018 |
K970291 |
ELEKTA INSTRUMENT AB |
ACCESSORIES TO THE STEREOTACTIC BODY FRAM |
04/24/1997 |
K960338 |
ELEKTA INSTRUMENT AB |
STEREOTACTIC BODY FRAME |
04/23/1996 |
K210500 |
Elekta Limited |
Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HD |
06/11/2021 |
K182076 |
Elekta Limited |
Elekta Unity |
12/04/2018 |
K192482 |
Elekta Limited |
Elekta Unity |
12/05/2019 |
K112613 |
Elekta Limited |
INTEGRITY(TM) |
12/16/2011 |
K153011 |
Elekta Limited |
iViewDose R1.0 |
12/11/2015 |
K192242 |
Elekta Limited |
Synergy Platform, Synergy, Infinity, VersaHD |
11/22/2019 |
K131965 |
Elekta Limited |
XVI R5.0 |
09/25/2013 |
K121328 |
ELEKTA LTD. |
AGILITY |
06/12/2012 |
K123808 |
ELEKTA LTD. |
AGILITY |
04/04/2013 |
K042794 |
ELEKTA LTD. |
BEAM MODULATOR, MODEL 4513 332 8000 |
01/31/2005 |
K121663 |
ELEKTA LTD. |
CLARITY |
12/05/2012 |
K141855 |
ELEKTA LTD. |
CLARITY |
10/08/2014 |
K111332 |
ELEKTA LTD. |
CLARITY OBP SYSTEM |
01/30/2012 |
K080585 |
ELEKTA LTD. |
DESKTOP PRO |
06/11/2008 |
K102200 |
ELEKTA LTD. |
INTEGRITY MODEL 1014284 |
11/04/2010 |
K082122 |
ELEKTA LTD. |
MLCI2 |
08/29/2008 |
K100115 |
ELEKTA LTD. |
XVI R4.5 |
03/10/2010 |
K973540 |
ELEKTA ONCOLOGY SYSTEMS, INC. |
ELEKTA ONCOLOGY SYSTEMS ICOM/QUICKMODE SOFTWARE OPTIONS |
12/17/1997 |
K032996 |
ELEKTA ONCOLOGY SYSTEMS, LTD. |
ELEKTA SYNERGY SYSTEM |
10/23/2003 |
K981790 |
ELEKTA ONCOLOGY SYSTEMS, LTD. |
IVIEW ELECTRONIC PORTAL IMAGING DEVICE (EPID) MODEL NUMBER IVEW |
08/07/1998 |
K012289 |
ELEKTA ONCOLOGY SYSTEMS, LTD. |
MODIFICATION TO: VIEWGT ELECTRONIC PORTAL IMAGING DEVICE (EPID) |
08/14/2001 |
K982713 |
ELEKTA ONCOLOGY SYSTEMS, LTD. |
RT DESKTOP |
11/02/1998 |
K212114 |
Elekta Solutions AB |
Elekta Unity |
10/01/2021 |
K223209 |
Elekta Solutions AB |
Elekta Unity |
02/23/2023 |
K203172 |
Elekta Solutions AB |
MOSAIQ Oncology Information System |
12/18/2020 |
K223229 |
Elekta Solutions AB |
MOSAIQ« OIS (Oncology Information System) |
02/23/2023 |
K051932 |
ELEKTA, INC |
ELEKTA SYNERGY; ELEKTA SYNERGY S AND XVIR3.5 |
08/12/2005 |
K183034 |
Elekta, Inc |
MOSAIQ Oncology Information System |
12/04/2018 |
K964485 |
ELIAV LTD. |
PORTPRO ELECTRONIC PORTAL IMAGING SYSTEM |
02/04/1997 |
K190894 |
Essebi Medical SRL |
TOTIM Patient Cushion Immobilization System |
04/30/2019 |
K171467 |
Focal Therapeutics |
BioZorb Marker GOLD / LP Marker GOLD |
11/09/2017 |
K070920 |
FUJIFILM MEDICAL SYSTEMS U.S.A., INC. |
FUJI IP CASSETTE TYPE PC |
05/22/2007 |
K954564 |
GAMMEX, INC. |
PID-1 PRECISION INTELLIGENT DOSIMETER |
04/22/1996 |
K113758 |
GE HEALTHCARE |
VOLUSON E6/E8/E8EXPERT/E10 |
01/10/2012 |
K965010 |
GE MEDICAL SYSTEMS |
TARGET 2 VERSION 1.1 |
07/23/1997 |
K150767 |
GUANGZHOU RAYDOSE SOFTWARE TECHNOLOGY., LLC |
EDOSE |
08/17/2015 |
K972617 |
HELAX AB |
HELAX-VISIR |
10/01/1997 |
K990209 |
HITESYS S.P.A. |
NOVAC7 |
06/22/2000 |
K982463 |
HOWMEDICA, INC. |
EXTRACRANIAL RADIOTHERAPY SYSTEM |
09/30/1998 |
K981153 |
HUESTIS MEDICAL |
OSIRIS |
03/17/1999 |
K112692 |
HUMEDIQ GMBH |
IDENTIFY |
08/03/2012 |
K014022 |
I.Z.I. CORP. |
MRI LINE MARKER |
03/04/2002 |
K993742 |
I.Z.I. CORP. |
SUPER TISSUE |
02/02/2000 |
K092018 |
IBA DOSIMETRY GMBH |
OMNIPRO INCLINE |
09/18/2009 |
K962335 |
IMPAC MEDICAL SYSTEMS, INC. |
MLC FIT |
02/06/1997 |
K991133 |
IMPAC MEDICAL SYSTEMS, INC. |
MLC FIT |
03/27/2000 |
K120067 |
IMPAC MEDICAL SYSTEMS, INC. |
MOSAIQ ONCOLOGY INFORMATION SYSTEM |
02/28/2012 |
K123230 |
IMPAC MEDICAL SYSTEMS, INC. |
MOSAIQ ONCOLOGY INFORMATION SYSTEM |
12/12/2012 |
K141572 |
IMPAC MEDICAL SYSTEMS, INC. |
MOSAIQ ONCOLOGY INFORMATION SYSTEM |
09/05/2014 |
K981313 |
IMPAC MEDICAL SYSTEMS, INC. |
SEQUENCER |
07/09/1998 |
K960510 |
INFIMED, INC. |
THERAVIEW |
04/22/1996 |
K072454 |
INTEGRA RADIONICS, INC. |
INTEGRA RADIONICS INTERFIX PATIENT ADAPTERS |
10/16/2007 |
K100096 |
INTEGRA RADIONICS, INC. |
LINAC COLLIMATOR ASSEMBLY HOUSING (LCAH) MODEL LCAHART |
04/22/2010 |
K990833 |
INTEGRITY MEDICAL SOFTWARE, INC. |
DOSE CALC, MODEL VS. 1.02 |
06/08/1999 |
K162629 |
IRT SYSTEMS |
IQM Integral Quality Monitor (also IQM) |
10/20/2016 |
K081218 |
IT-V MEDIZINTECHNIK, GMBH |
BELLYSTEP, HEADSTEP, BREASTSTEP, PROSTEP, WINGSTEP AND ICAST |
07/21/2008 |
K162265 |
IZI Medical Products LLC |
CushionCast Moldable Cushions |
11/15/2016 |
K192405 |
Jiangsu Rayer Medical Technology Co., Ltd. |
Image Guidance System for Radiotherapy |
05/01/2020 |
K202747 |
Klarity Medical & Equipment (GZ) Co., Ltd. |
Klarity Bolus |
05/14/2021 |
K220539 |
Klarity Medical & Equipment (GZ) Co., Ltd. |
Klarity SRS Baseplate, Klarity Promise Baseplate |
11/01/2022 |
K132124 |
KLARITY MEDICAL PRODUCTS, LLC |
KLARITY VACUUM BAG, KLARITY MOLD CUSHION |
11/01/2013 |
K192196 |
Landauer |
Medical Radiation Dosimetry System microSTARii |
12/27/2019 |
K173926 |
LAP GmbH Laser Applikationen |
DORADOnova MR3T |
09/14/2018 |
K200907 |
LAP GmbH Laser Applikationen |
Thales 3D Mr Scanner |
06/03/2020 |
K112460 |
LARSON MEDICAL PRODUCTS, INC. |
MULTIPLE |
10/07/2011 |
K022708 |
LARSON PRODUCTS, INC. |
KLARITY |
11/12/2002 |
K010464 |
LIFELINE SOFTWARE, INC. |
RADCALC, MODEL V.4.0 |
05/17/2001 |
K092550 |
LINATECH, LLC |
TIGRT IVS |
12/15/2009 |
K090802 |
LINATECH, LLC |
TIGRT MLC, TIGRT DMLC |
07/07/2009 |
K222977 |
MacroMedics BV |
DSPS-ProminentÖ Masks; DSPS-ProminentÖ Baseplate, MR; CouchStrip |
02/17/2023 |
K213439 |
MacroMedics BV |
FlexBoardTM, EagleBoardTM, BreastBoard SXTM |
06/24/2022 |
K142420 |
MACROMEDICS BV |
Patient Positioning Devices |
03/27/2015 |
K212909 |
MacroMedics BV |
VacuumCushions, FeetSupports, LEPS (Lower Extermities Positioning System), CouchStrips |
05/11/2022 |
K213526 |
MagnetTx Oncology Solutions Ltd. |
Aurora-RT |
05/04/2022 |
K223834 |
Manteia Technologies Co., Ltd. |
AccuCheck |
07/20/2023 |
K162577 |
MATH RESOLUTIONS, LLC |
Dosimetry Check Version 5 Release 1 |
11/18/2016 |
K010225 |
MATH RESOLUTIONS, LLC. |
DOSIMETRY CHECK |
04/24/2001 |
K132605 |
MATH RESOLUTIONS, LLC. |
DOSIMETRY CHECK VERSION 4 RELEASE 1 |
11/14/2013 |
K101503 |
MATH RESOLUTIONS, LLC. |
DUSIMETRY CHECK |
08/04/2010 |
K011845 |
MATH RESOLUTIONS, LLC. |
MILLCOMP |
12/04/2001 |
K050372 |
MATH RESOLUTIONS, LLC. |
VISITRAK, VERSION 1, RELEASE 1 |
03/25/2005 |
K001052 |
MED-TEC,INC. |
MED-TEC (MEDICAL INTELLIGENCE) BODYFIX SYSTEM, MODEL MT-BFX |
08/30/2000 |
K023293 |
MED-TEC,INC. |
MED-TEC BELLYBOARD, MODELS MT-BBA-01 & MT-BBA-02 |
12/23/2002 |
K982624 |
MED-TEC,INC. |
MOLDCARE HEAD & NECK CUSHION, MODEL # MT-ACL-14242 |
10/26/1998 |
K102237 |
MEDCOM GMBH |
PVS MODEL 1.0 |
11/23/2010 |
K080742 |
MEDCOM GMBH |
VERISUITE 1.6, VERISUITE-PARTICLE 1.6 |
05/09/2008 |
K980904 |
MEDICAL DOSIMETRY SERVICES, INC. |
MUCHECK MONITOR UNIT VALIDATION PROGRAM |
06/08/1998 |
K991336 |
MEDICAL INSTRUMENTATION & DIAGNOSTICS CORP.(MIDCO) |
BODYLOC WHOLE BODY STEREOTACTIC LOCALIZER SYSTEM FOR RADIOTHERAPY |
07/12/1999 |
K961484 |
MEDICAL INSTRUMENTATION & DIAGNOSTICS CORP.(MIDCO) |
CASS SYSTEM (MODIFICATION) |
11/07/1996 |
K013391 |
MEDICAL INTELLIGENCE MEDIZINTECHNIK GMBH |
BODYFIX |
01/11/2002 |
K121530 |
MEDICAL INTELLIGENCE MEDIZINTECHNIK GMBH |
BODYFIX SYSTEM |
06/20/2012 |
K112210 |
MEDICAL INTELLIGENCE MEDIZINTECHNIK GMBH |
FRAXION |
11/22/2011 |
K030439 |
MEDICAL INTELLIGENCE MEDIZINTECHNIK GMBH |
HEADFIX |
05/08/2003 |
K143485 |
MEDICAL INTELLIGENCE MEDIZINTECHNIK GMBH |
iGuide 2.1 |
03/04/2015 |
K062611 |
MEDICAL INTELLIGENCE MEDIZINTECHNIK-GMBH-AN ELEKTA |
IGUIDE SYSTEM |
09/20/2006 |
K072079 |
MEDICAL INTELLIGENCE MEDIZINTECHNIK-GMBH-AN ELEKTA |
IGUIDE SYSTEM |
08/14/2007 |
K953508 |
MEDICALIBRATION PHYSICS CONSULTANT SERVICES, INC. |
COMPUTE-RX PLAN PC3D |
02/26/1996 |
K161400 |
MEDPHOTON GMBH |
ImagingRing System |
12/08/2016 |
K191267 |
MedPhoton GmbH |
ImagingRing System on Rails |
08/01/2019 |
K180021 |
MEDTEC Inc dba CIVCO Medical Solutions and CIVCO Radiotherap |
Proton Positioing and Immobilization Devices |
06/29/2018 |
K182079 |
MEDTEC Inc. dba CIVCO Medical Solutions |
Solstice SRS Immobilization System; Solstat Immobilization System; Solstice Thermoplastic Mask |
09/07/2018 |
K954705 |
MEDTEC, INC. |
ACRYSTEEL BLOCKING TRAY |
01/05/1996 |
K974703 |
MEDTEC, INC. |
CARBON FIBER BREAST BOARD |
03/10/1998 |
K974700 |
MEDTEC, INC. |
MATRIX MT-MX3 |
03/04/1998 |
K132908 |
MEDTEC, INC. |
TRUPOINT ARCH, NASION CUSHION, BITE CUP, TRUPOINT ARCH STORAGE PLATE, TRUPOINT ARCH BASE LOCK REPLACEMENT KIT |
03/04/2014 |
K153026 |
MEDTEC, INC. D/B/A CIVCO MEDICAL SOLUTIONS |
Body Pro-Lok Respiratory Plate, Respiratory Plate Cushion, Body Pro-Respiratory Belt, Rail Clamp for Respiratory Belt, Pressure Gauge Replacement |
05/25/2016 |
K211001 |
MEDTEC, Inc. dba CIVCO Medical Solutions and CIVCO |
C-Qual MÖ Breastboard; MonarchÖ Overhead Arm Positioner |
05/20/2021 |
K972804 |
MGS RESEARCH, INC. |
BANG POLYMER GEL DOSIMETER, BANG 533 |
10/23/1997 |
K993959 |
MICK RADIO-NUCLEAR INSTRUMENTS, INC. |
ISOCENTRIC BEAM CHECKER |
02/14/2000 |
K993960 |
MICK RADIO-NUCLEAR INSTRUMENTS, INC. |
PERMA-DOC PHANTOM |
02/14/2000 |
K991107 |
MICK RADIO-NUCLEAR INSTRUMENTS, INC. |
SHADOW TRAYS |
06/29/1999 |
K972709 |
MICK RADIO-NUCLEAR INSTRUMENTS, INC. |
TBI STAND |
10/16/1997 |
K203722 |
Micropos Medical AB |
RayPilot System |
09/02/2021 |
K973963 |
MITSUBISHI ELECTRONICS AMERICA, INC. |
120 LEAF MULTILEAF COLLIMATOR |
01/14/1998 |
K970564 |
MITSUBISHI ELECTRONICS AMERICA, INC. |
DYNAMIC WEDGE |
05/12/1997 |
K970137 |
MITSUBISHI ELECTRONICS AMERICA, INC. |
EXL-12SP,12DP,15DP,20DP LINAC |
04/15/1997 |
K072047 |
MITSUBISHI HEAVY INDUSTRIES, LTD. |
MHI-TM2000 LINEAR ACCELERATOR SYSTEM |
08/29/2007 |
K122450 |
MITSUBISHI HEAVY INDUSTRIES, LTD. |
MHI-TM2000 LINEAR ACCELERATOR SYSTEM VERO IMAVIS |
10/03/2012 |
K152867 |
MITSUBISHI HEAVY INDUSTRIES, LTD. |
MHI-TM2000 Linear Accelerator System, VERO, Imavis |
10/21/2015 |
K952314 |
MITSUBISHI INTL. CORP. |
EXL-12SP & 12DP LINAC |
01/17/1996 |
K961214 |
MITSUBISHI INTL. CORP. |
MULTI LEAF COLLIMATOR |
08/06/1996 |
K141230 |
MOBIUS MEDICAL SYSTEMS, LP |
DOSELAB PRO |
08/27/2014 |
K140660 |
MOBIUS MEDICAL SYSTEMS, LP |
MOBIUS3D |
06/24/2014 |
K153014 |
MOBIUS MEDICAL SYSTEMS, LP |
Mobius3D |
04/29/2016 |
K964167 |
MULTIDATA SYSTEMS INTERNATIONAL CORP. |
DECISION SUPPORT SYSTEM (FOR RADIATION ONCOLOGY) |
03/21/1997 |
K201117 |
Naslund Medical AB |
Gold Anchor |
06/11/2020 |
K213053 |
Naslund Medical AB |
Gold Anchor |
01/06/2022 |
K091645 |
NASLUND MEDICAL AB |
GOLD ANCHOR |
07/21/2009 |
K160209 |
NASLUND MEDICAL AB |
Gold Anchor |
06/21/2016 |
K100625 |
NAVOTEK MEDICAL LTD |
REALEYE MODEL VCPS |
01/21/2011 |
K110971 |
NAVOTEK MEDICAL LTD |
TRACER IMPLANTATION KIT, INDEX IMPLANTATION KIT |
01/10/2012 |
K112286 |
NEW RADIANT TECHNOLOGY S.P.A. |
NOVAC 11 |
04/19/2012 |
K092845 |
NOMICS |
RESPISENS |
01/26/2010 |
K070611 |
NOMOS CORP. |
BAT ULTRASOUND LOCALIZATION AND POSITIONING SYSTEM, VERSION 6 |
07/11/2007 |
K972451 |
NOMOS CORP. |
COREGISTRATION FUNCTION |
01/22/1998 |
K042875 |
NOMOS CORP. |
NAVIGATOR |
07/01/2005 |
K981424 |
NOMOS CORP. |
NOMOS BAT ULTRASOUND LOCALIZATION AND POSITIONING SYSTEM |
07/17/1998 |
K974310 |
NOMOS CORP. |
NOMOS SLIT COLLIMATOR (BEAK) |
02/06/1998 |
K060895 |
NOMOS CORP. |
NOMOSSTAT, VERSION 1.0 |
07/21/2006 |
K940663 |
NOMOS CORP. |
PEACOCK PLAN |
04/09/1996 |
K963258 |
NOMOS CORP. |
PEACOCK SYSTEM |
11/18/1996 |
K993359 |
NOMOS CORP. |
RAPTOR TREATMENT PLANNING SYSTEM |
12/21/1999 |
K991966 |
NOMOS CORP. |
THE NOMOS CHANE II |
09/03/1999 |
K963860 |
NOMOS CORP. |
THE NOMOS TALON POSITIONING AND IMMOBILIZATION SYSTEM |
12/23/1996 |
K063274 |
NORTHWEST MEDICAL PHYSICS EQUIPMENT, INC. |
ACCULOC BREAST LOCALIZATION SYSTEM |
12/12/2006 |
K960293 |
NORTHWEST MEDICAL PHYSICS EQUIPMENT, INC. |
MRTOFLM COMPUTER PROGRAM |
08/01/1996 |
K970464 |
NORTHWEST MEDICAL PHYSICS EQUIPMENT, INC. |
P REFERENCE TPS (TREATMENT PLANNING SOFTWARE) 1.1 |
09/05/1997 |
K001833 |
NORTHWEST MEDICAL PHYSICS EQUIPMENT, INC. |
PREFERENCE TREATMENT SYSTEM |
09/28/2000 |
K964206 |
NUCLETRON CORP. |
NUCLETRON PLATO EXTERNAL BEAM PLANNING RTS V2 AND RTS 3D V2 |
06/20/1997 |
K980629 |
NUCLETRON CORP. |
VSS, VIRTUAL SIMULATION SYSTEM |
05/06/1998 |
K073273 |
NUCLETRON CORPORATION |
EQUAL DOSE 1.0 |
12/11/2007 |
K071673 |
ONC SOLUTIONS, INC. |
ONC SOLUTIONS MARKER, MODELS 001001 TO 001012 AND 001021 TO 001032 |
07/18/2007 |
K092939 |
ONCOLOG MEDICAL QA AB |
PATLOG 2.0 |
10/09/2009 |
K090044 |
ONCOLOG MEDICAL QA AB |
PATLOG, PATLOG PATIENT HANDLING SYSTEM, PATLOG TOPLOG TABLE TOP, MODEL(S) 1.0, 1.0, C |
01/22/2009 |
K012227 |
ONCOLOGY DATA SYSTEMS, INC. |
MUCHECK - MONITOR UNIT VALIDATION PROGRAM, MODEL V4.1 |
10/01/2001 |
K091602 |
ONCOLOGY DATA SYSTEMS, INC. |
MUCHECK V8 |
06/18/2009 |
K102583 |
ONCOLOGY DATA SYSTEMS, INC. |
MUCHECK, VERSION 9.0 |
11/02/2010 |
K090349 |
ORBITAL THERAPY, LLC |
CLEARVUE PRONE BREAST TREATMENT TABLE |
03/09/2009 |
K991319 |
ORFIT INDUSTRIES |
RAYCAST IMMOBILIZATION SYSTEMS HARDWARE AND THERMOPLASTIC MATERIALS |
09/21/1999 |
K151946 |
ORFIT INDUSTRIES |
Thermofit |
11/09/2015 |
K171734 |
Orfit Industries NV |
HP PRO Positioning Device |
07/25/2017 |
K131795 |
ORFIT INDUSTRIES NV |
NANOR AND EFFICAST/NANOR HYBRID THERMOPLASTIC MATERIALS |
09/26/2013 |
K151207 |
ORFIT INDUSTRIES NV |
Proton Immobilization Solution |
07/28/2015 |
K162862 |
Orfit Industries NV |
Raycast High Precision Lung Board Solution |
11/09/2016 |
K162355 |
Orfit Industries NV |
Raycast MammoRx Carbon Fibre Breast Board |
11/22/2016 |
K141787 |
ORFIT INDUSTRIES NV |
SAGITTILT |
08/07/2014 |
K191158 |
Orfit Industries NV |
The AIO Solution |
08/06/2019 |
K202068 |
Orfit Industries NV |
The AIO Solution 3.0 |
08/14/2020 |
K193207 |
Our United Corporation |
TaiChiA |
08/07/2020 |
K210921 |
Our United Corporation |
TaiChiB |
11/02/2021 |
K092424 |
P-CURE LTD |
P-ART, MODEL 001 |
03/05/2010 |
K222762 |
Panacea Medical Technologies Pvt Ltd |
SIDDHARTH-II;IMPACT |
06/08/2023 |
K210894 |
Panacea Medical Technologies Pvt.Ltd |
SIDDHARTH-II; IMPACT |
09/28/2021 |
K963624 |
PHILIPS MEDICAL SYSTEMS, INC. |
PHILIPS SLI SERIES LINEAR ACCELERATOR |
12/06/1996 |
K130992 |
PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. |
PINNACLE3 RADIATION THERAPY PLANNING SYSTEM |
06/14/2013 |
K183374 |
POLL Medical LLC |
GrayDuck Stent |
02/26/2019 |
K990383 |
PRECITRON A.B. |
APOLLO 5, APOLLO 10 |
05/05/1999 |
K031975 |
PRODIGM, INC. |
IMSURE |
08/29/2003 |
K121657 |
PROTON SYSTEMS |
PROTON RADIATION THERAPY BEAM-SHAPING APERTURE PROTON RADIAION THERAPY BEAM-SHPING RANGE COMPENSATOR |
10/23/2012 |
K211760 |
Prowess Inc. |
Panther OIS |
09/28/2021 |
K122616 |
PROWESS, INC. |
PANTHER OIS/R & V MODEL VERSION 2.0 |
12/21/2012 |
K100801 |
PROWESS, INC. |
PUMA MODEL VERSION 1.0 |
06/18/2010 |
K161807 |
PTW-Freiburg Physikalisch Technische-Werksraetten |
BEAMSCAN |
05/19/2017 |
K191646 |
PTW-Freiburg Physikalisch-Technische-Werkstaetten |
Beamscan MR |
02/21/2020 |
K160405 |
PTW-FREIBURG PHYSIKALISCH-TECHNISCHE-WERKSTAETTEN |
OCTAVIUS I, OCTAVIUS II, OCTAVIUS III, OCTAVIUS 4D |
10/20/2017 |
K213370 |
PTW-Freiburg Physikalisch-Technische-Werkstaetten |
VERIQA |
03/30/2022 |
K961208 |
PTW-NEW YORK CORP. |
0.6CC IONIZATION CHAMBER - WATERPROOF 0.6CC IONIZATION CHAMBER |
06/17/1996 |
K062817 |
PTW-NEW YORK CORP. |
PTW DAVID IMRT QC VERIFICATION SYSTEM |
11/22/2006 |
K010916 |
PTW-NEW YORK CORP. |
PTW DOSIMETRY DIODE, T60008 |
06/20/2001 |
K193243 |
Qfix |
Alta Multipurpose Device |
02/28/2020 |
K182189 |
Qfix |
Encompass SRS Headframe ; Encompass MR SRS Headframe |
10/04/2018 |
K230312 |
Qfix |
Iris AirShuttleÖ |
03/31/2023 |
K152321 |
QFIX |
kVue Encompass SRS Insert (Encompass Insert), Encompass SRS Standalone (Encompass Device), Encompass SRS MRI Immobilization device (Encompass MRI Device, Encompass Intracranial Fibreplast Variable Perf Head Only Open View System, Encompass Intracranial Fi |
12/04/2015 |
K171133 |
Qfix |
Qfix« Abdominal/Thoracic Motion Control System,Qfix« SBRT Solution and Accessories |
07/11/2017 |
K160627 |
QFIX |
Symphony Patient Transport System, Symphony Patient Trolley, Symphony Standard Transfer Surface, Symphony Portrait (Head/Neck) Transfer Surface, Symphony Brachytherapy solution |
06/14/2016 |
K172534 |
QualiFormeD Sarl |
LINACwatch, LinacView |
10/27/2017 |
K992689 |
RAD THERAPY SOLUTIONS, INC. |
MU PLUS |
02/10/2000 |
K162468 |
RADFORMATION |
ClearCheck |
12/01/2016 |
K201119 |
Radformation, Inc. |
ChartCheck |
06/26/2020 |
K220583 |
Radformation, Inc. |
ClearCheck Model RADCC V2 |
08/23/2022 |
K171350 |
Radformation, Inc. |
Collision Check |
11/29/2017 |
K171352 |
Radformation, Inc. |
EZFluence |
12/01/2017 |
K180595 |
Radialogica LLC |
SciMoCa |
04/04/2018 |
K984241 |
RADIATION ONCOLOGY COMPUTER SYSTEMS |
ROCS ULTRASEED |
05/12/1999 |
K150382 |
RADIATION PRODUCTS DESIGN, INC. |
Radio Therapy Treatment Chair |
09/16/2015 |
K180027 |
Radiation Products LLC |
ACCUSYTE 3D Fiducial Marker |
07/18/2018 |
K070305 |
RADIOMED CORPORATION |
PRE-LOADED VISICOIL |
03/07/2007 |
K161724 |
RadioMed Corporation |
Visicoil MR Marker (User Loaded), Visicoil MR Marker (Pre-Loaded) |
04/28/2017 |
K962155 |
RADIONICS SOFTWARE APPLICATIONS, INC. |
GILL-THOMAS-COSMAN(GTC) DENTAL TRAY |
08/22/1996 |
K972905 |
RADIONICS SOFTWARE APPLICATIONS, INC. |
XPLAN-1 |
10/28/1997 |
K023519 |
RADIONICS, A DIVISION OF TYCO HEALTHCARE GROUP LP |
RADIONICS VARILINK 2 |
01/16/2003 |
K993594 |
RADIONICS, INC. |
CONFORMAX MMLC VR1 |
12/15/1999 |
K982549 |
RADIONICS, INC. |
RADIONICS MINI MULTI-LEAF COLLIMATOR, MODEL RADIONICS MMLC |
12/30/1998 |
K981597 |
RADIONICS, INC. |
RADIONICS SLICE EDITOR IMAGING SOFTWARE UTILITY |
10/09/1998 |
K991523 |
RADIONICS, INC. |
TLC PEDIATRIC FRAME, MODEL TLC-SYS |
07/30/1999 |
K981055 |
RADIONICS, INC. |
XKNIFE-4 |
09/29/1998 |
K200652 |
RadTec Medical Devices, Inc. |
Lollipop BiteBlock |
07/06/2020 |
K190978 |
RefleXion Medical, Inc. |
RefleXion Medical Radiotherapy System |
03/12/2020 |
K041937 |
RESONANT MEDICAL, INC. |
RESTITU |
11/16/2004 |
K180697 |
RTsafe, Inc. |
Pseudo-Patient |
07/10/2018 |
K961170 |
S. AND H. ENGINEERING, INC. |
BREAST TREATMENT AID |
06/19/1996 |
K962487 |
S. AND H. ENGINEERING, INC. |
BREAST TREATMENT AID M200 |
09/09/1996 |
K961467 |
S. AND H. ENGINEERING, INC. |
HEAD RETAINING DEVICE |
08/09/1996 |
K052920 |
SCANDIDOS AB |
DELTA4 |
01/12/2006 |
K183606 |
ScandiDos AB |
Delta4 Phantom+ MR (PMMA), Delta4 Phantom+ MR (PW) |
04/08/2019 |
K151426 |
SCANDIDOS AB |
ScandiDos Delta4 Discover, Alternative Trade Name: ScandiDos Delta4 Discover+ |
01/29/2016 |
K151180 |
SCANDIDOS AB |
ScandiDos Delta4 Phantom+ |
08/19/2015 |
K990734 |
SCANDITRONIX MEDICAL AB |
DPD-12PCC |
05/28/1999 |
K002051 |
SCANDITRONIX MEDICAL AB |
INVIDOS |
09/05/2000 |
K011763 |
SCANDITRONIX MEDICAL AB |
OMNIDOS |
09/05/2001 |
K961400 |
SCANDITRONIX MEDICAL AB |
RFA-300, LDA UTILITY |
01/03/1997 |
K072374 |
SCANDITRONIX WELLHOFER GMBH |
COMPASS |
12/07/2007 |
K000209 |
SCANDITRONIX WELLHOFER NORTH AMERICA |
DOSE 1 |
08/18/2000 |
K040687 |
SICEL TECHNOLOGIES INC |
ONEDOSE PATIENT DOSIMETRY SYSTEM |
06/25/2004 |
K081859 |
SICEL TECHNOLOGIES, INC. |
MODIFICATION TO ONEDOSE PATIENT DOSIMETRY SYSTEM |
08/04/2008 |
K092145 |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
160MLC OPTION |
09/18/2009 |
K072485 |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
ARTISTE MV SA |
12/27/2007 |
K103606 |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
ARTISTE SOLUTION WITH SYS_VB50 UPDATE |
04/15/2011 |
K132935 |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
ARTISTE SOLUTION WITH SYS_VC10C AND SYNGO RT THERAPIST WORKSPACE, V4.3.1 UPGRADE KIT, ARIA CONNECTIVITY OPTION FOR SIEME |
02/21/2014 |
K142434 |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
ARTISTE SOLUTION, SYS_VC10C, PHASE 2 UPDATE WITH THE SYNGO RT THERAPIST & RT ONCOLOGIST WORKSPACES, V4.3.1_MR1 |
11/21/2014 |
K121295 |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
ARTISTETM SOLUTION WITH SYS VCIO |
06/27/2012 |
K060633 |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
COHERENCE ONCOLOGIST WORKSPACE, MODEL 2.0 AND PHYSICIST WORKSPACE, MODEL 1.0 |
05/01/2006 |
K123812 |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
COHERENCE RT THERAPIST CONNECT WORKSPACE, V2.3, ARIA CONNECTIVITY OPTION FOR SIEMENS NON-IMAGING SYSTEMS, ARIA CONNECTIV |
03/01/2013 |
K982502 |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
GENESIS IMRT LINEAR ACCELERATOR |
07/31/1998 |
K972275 |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
LANTIS TREATSTATION |
09/08/1997 |
K182050 |
Siemens Medical Solutions USA, Inc. |
Linear Accelerator Control Console Software v13.1.010 Update, syngo Radiation Therapy Therapist v4.3.1_MR3 Patch, syngo Radiation Therapy Oncologist v4.3.1_MR3 Patch |
10/03/2018 |
K982513 |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
MX MEVATRON |
07/31/1998 |
K031764 |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
ONCOR AVANT-GARDE WITH COHERENCE WORKSPACES |
09/05/2003 |
K060226 |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
ONCOR EXPRESSION |
03/15/2006 |
K082775 |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
PRESCISION OPTION |
02/19/2009 |
K993425 |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
PRIMUS |
11/26/1999 |
K090683 |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
SYNGO RT THERAPIST CONNECT |
05/08/2009 |
K102671 |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
SYNGO RT THERAPIST CONNECT WORKSPACE, V4.2 |
10/12/2010 |
K060737 |
SINMED BV |
SINMED POSITIONING DEVICES |
03/31/2006 |
K172961 |
Sit Sordina Iort Technologies Spa |
LIAC HWL |
06/11/2018 |
K182374 |
Sit Sordina Iort Technologies Spa |
LIAC S |
05/22/2019 |
K962080 |
SOFIELD SCIENCE SERVICES, INC. |
RPS-50 BEAM SCANNER |
08/23/1996 |
K110840 |
SORDINA S.P.A. |
LIAC |
04/17/2012 |
K023636 |
SOUTHEASTERN RADIATION PRODUCTS, INC. |
BLOCKING TRAY |
11/22/2002 |
K980379 |
SSGI PROWESS SYSTEMS |
PROWESS PRO-SIM |
05/18/1998 |
K103193 |
STANDARD IMAGING, INC. |
DOSEVIEW 3D |
12/27/2010 |
K082773 |
STANDARD IMAGING, INC. |
STANDARD IMAGING IMSURE BRACHY QA SOFTWARE, MODEL 91331 |
11/19/2008 |
K092041 |
STELLAR MEDICAL LLC. |
STELLAR FIDUCIAL MARKER, MODEL GFMIA |
10/02/2009 |
K023449 |
STRYKER LEIBINGER |
NON-INVASIVE PATIENT FIXATION SYSTEM |
01/13/2003 |
K020320 |
STYKER INSTRUMENTS |
RADIOSYSTEM/NT, MODEL 80-13020 |
08/28/2002 |
K101992 |
SUN NUCLEAR CORP. |
3D SCANNER, MODEL 1230 |
10/01/2010 |
K010449 |
SUN NUCLEAR CORP. |
IVD (IN VIVO DOSIMETER), MODEL 1131 |
05/04/2001 |
K092019 |
SUN NUCLEAR CORP. |
MODEL 1014 PC ELECTROMETER |
09/15/2009 |
K021463 |
SUN NUCLEAR CORP. |
MODEL 1133 IVD PC VERSION |
06/06/2002 |
K002444 |
SUN NUCLEAR CORP. |
PRECISION DOSIMETRY ELECTROMETER, MODEL 1010 OR 206 |
10/18/2000 |
K063021 |
SUN NUCLEAR CORP. |
PROFILER 2 |
11/22/2006 |
K011332 |
SUN NUCLEAR CORP. |
RF-IVD WIRELESS DOSIMETER-MODEL 1133 |
07/26/2001 |
K051921 |
SUN NUCLEAR CORP. |
THE EDGE DETECTOR, MODEL 1118 |
07/27/2005 |
K131862 |
SUN NUCLEAR CORPORATION |
3DVH |
08/21/2013 |
K142617 |
SUN NUCLEAR CORPORATION |
ArcCHECK |
11/20/2015 |
K160057 |
Sun Nuclear Corporation |
ArcCHECK-MR |
05/13/2016 |
K150848 |
SUN NUCLEAR CORPORATION |
Dose Calculator |
05/20/2015 |
K161946 |
Sun Nuclear Corporation |
DoseCHECK |
09/16/2016 |
K131704 |
SUN NUCLEAR CORPORATION |
EPIDOSE |
08/05/2013 |
K131466 |
SUN NUCLEAR CORPORATION |
MAPCHECK2, ARCCHECK |
08/20/2013 |
K141800 |
SUN NUCLEAR CORPORATION |
PERFRACTION |
09/26/2014 |
K142142 |
SUN NUCLEAR CORPORATION |
QUALITY REPORTS |
12/05/2014 |
K170307 |
SUN NUCLEAR CORPORATION |
SunCHECK |
10/25/2017 |
K142431 |
SUN NUCLEAR CORPORATION |
WaterProof PROFILER |
12/05/2014 |
K964517 |
SURGICAL NAVIGATION TECHNOLOGIES, INC. |
LINAC SCALPEL FLOORSTAND |
04/01/1997 |
K962792 |
SURGICAL NAVIGATION TECHNOLOGIES, INC. |
LINAC SCALPEL TREATMENT PLANNING SYSTEM |
11/12/1996 |
K981346 |
SURGICAL NAVIGATION TECHNOLOGIES, INC. |
RADIOCAMERAS BITEBLOCK LOCALIZATION AND POSITIONING SYSTEM |
07/10/1998 |
K000246 |
SURGICAL NAVIGATION TECHNOLOGIES, INC. |
RADIOCAMERAS EXTRACRANIAL SYSTEM |
10/20/2000 |
K980750 |
SURGICAL NAVIGATION TECHNOLOGIES, INC. |
RADIOCAMERAS PATIENT POSITIONING SYSTEM |
05/20/1998 |
K994355 |
SURGICAL NAVIGATION TECHNOLOGIES, INC. |
RADIOCAMERAS SYSTEM HEAD/NECK APPLICATION |
03/22/2000 |
K971893 |
SURGICAL NAVIGATION TECHNOLOGIES, INC. |
SNT LINAC ACCESSORIES |
11/13/1997 |
K024284 |
SYNCOR RADIATION MANAGEMENT |
VICTOREEN THEBES II, MODEL 7020 |
03/11/2003 |
K082909 |
THE PHANTOM LABORATORY, INC. |
RSVP HALF SPHERE PHANTOM, MODEL DDP010 |
12/23/2008 |
K081760 |
THE PHANTOM LABORATORY, INC. |
RSVP PHANTOM PELVIS, MODEL TLP260 |
07/29/2008 |
K954679 |
THERATRONICS, INC. |
THERAPLAN PLUS |
11/08/1996 |
K970236 |
THERATRONICS, INC. |
THERAPLAN PLUS VERSION 1.2 |
07/09/1997 |
K041557 |
THOMSON & NIELSEN ELECTRONICS, LTD. |
MOBILEMOSFET WIRELESS DOSIMETRY SYSTEM, MODEL TN-RD-70-W |
06/25/2004 |
K032725 |
THOMSON & NIELSEN ELECTRONICS, LTD. |
MOSFET AUTOSENSE WIRELESS |
10/03/2003 |
K013279 |
THOMSON & NIELSEN ELECTRONICS, LTD. |
MOSFET AUTOSENSE, MODEL TN-RD-60 |
10/18/2001 |
K010472 |
THOMSON & NIELSEN ELECTRONICS, LTD. |
PATIENT DOSE VERIFICATION SYSTEM, MODEL TN-RD-50 |
05/08/2001 |
K033347 |
TOMOTHERAPY INCORPORATED |
MODIFICATION TO: HI-ART SYSTEM |
11/12/2003 |
K060912 |
TOMOTHERAPY INCORPORATED |
MODIFICATION TO: HI-ART SYSTEM |
04/19/2006 |
K963451 |
TOPSLANE |
ANTI-TUMOR EXPERT SYSTEM (ATES) FOR RADIATION THERAPY TREATMENT PLANNING |
08/05/1997 |
K990085 |
VARIAN ASSOC., INC. |
MILLENNIUM MLC -120 |
02/08/1999 |
K943224 |
VARIAN ASSOC., INC. |
VARIAN MULTILEAF COLLIMATOR |
02/02/1996 |
K955774 |
VARIAN ASSOC., INC. |
VARIS PORTALVISION |
03/15/1996 |
K140528 |
VARIAN MEDICAL SYSTEMS, INC. |
TRUE BEAM, TRUE BEAM STX, EDGE |
09/05/2014 |
K050479 |
VARIAN MEDICAL SYSTEMS |
4D INTEGRATED TREATMENT CONSOLE |
03/24/2005 |
K091132 |
VARIAN MEDICAL SYSTEMS |
4D INTEGRATED TREATMENT CONSOLE |
06/17/2009 |
K123137 |
VARIAN MEDICAL SYSTEMS |
CALYPSO SYSTEM |
12/05/2012 |
K071992 |
VARIAN MEDICAL SYSTEMS |
HIGH-DEFINITION 120 MULTILEAF COLLIMATOR (HD120 MLC) |
08/15/2007 |
K050442 |
VARIAN MEDICAL SYSTEMS |
MILLENNIUM MULTI-LEAF COLLIMATOR |
03/23/2005 |
K042720 |
VARIAN MEDICAL SYSTEMS |
ON-BOARD IMAGER DEVICE |
10/29/2004 |
K102024 |
VARIAN MEDICAL SYSTEMS |
RPM RESPIRATORY GATING SYSTEM |
10/15/2010 |
K112778 |
VARIAN MEDICAL SYSTEMS |
SMART SEGMENTATION-KNOWLEDGE BASED CONTOURING |
12/29/2011 |
K061140 |
VARIAN MEDICAL SYSTEMS |
TRILOGY RADIOTHERAPY DELIVERY SYSTEM |
05/15/2006 |
K100890 |
VARIAN MEDICAL SYSTEMS |
VARIAN HIGH ENERGY LINEAR ACCELERATOR |
07/13/2010 |
K112839 |
VARIAN MEDICAL SYSTEMS |
VARIAN HIGH ENERGY LINEAR ACCELERATOR |
11/14/2011 |
K052391 |
VARIAN MEDICAL SYSTEMS |
VISION (WITH OFF-LINE REVIEW) |
11/23/2005 |
K170570 |
Varian Medical Systems Inc |
Anchored Beacon(R) transponder, Anchored transponder, Beacon Care Package - Lung |
04/06/2018 |
K230699 |
Varian Medical Systems Inc. |
ARIA Radiation Therapy Management (v18.0) |
04/10/2023 |
K170817 |
Varian Medical Systems Inc. |
Halcyon |
06/27/2017 |
K181032 |
Varian Medical Systems Inc. |
Halcyon |
05/09/2018 |
K190137 |
Varian Medical Systems Inc. |
Identify |
07/10/2019 |
K210835 |
Varian Medical Systems Inc. |
Identify |
04/20/2021 |
K230576 |
Varian Medical Systems Inc. |
IDENTIFY |
07/25/2023 |
K221448 |
Varian Medical Systems, Inc |
ARIA Radiation Therapy Management (v15.8), Eclipse Treatment Planning System (v15.8) |
06/15/2022 |
K221408 |
Varian Medical Systems, Inc |
ARIA Radiation Therapy Management (v16.1 MR3) |
06/17/2022 |
K222941 |
Varian Medical Systems, Inc |
Halcyon, Ethos Radiotherapy System |
01/17/2023 |
K191761 |
Varian Medical Systems, Inc |
Mobius3D |
07/31/2019 |
K192424 |
Varian Medical Systems, Inc |
Mobius3D |
10/03/2019 |
K081036 |
VARIAN MEDICAL SYSTEMS, INC. |
4D INTEGRATED TREATMENT CONSOLE WITH PATIENT ACCESSORY VERIFICATION SYSTEM (PAVS) |
05/09/2008 |
K093527 |
VARIAN MEDICAL SYSTEMS, INC. |
ARIA RADIATION ONCOLOGY WITH MIRS |
12/15/2009 |
K173838 |
Varian Medical Systems, Inc. |
ARIA Radiation Therapy Management |
01/17/2018 |
K133572 |
VARIAN MEDICAL SYSTEMS, INC. |
ARIA RADIATION THERAPY MANAGEMENT |
04/04/2014 |
K962950 |
VARIAN MEDICAL SYSTEMS, INC. |
CADPLAN, VERSION 2.62. RADIATION THERAPY TREATMENT PLANNING SYSTEM |
07/22/1997 |
K010975 |
VARIAN MEDICAL SYSTEMS, INC. |
ECLIPSE 6.5 |
05/02/2001 |
K212294 |
Varian Medical Systems, Inc. |
Ethos Treatment Management, Ethos Treatment Planning |
08/20/2021 |
K192377 |
Varian Medical Systems, Inc. |
Ethos Treatment Management, Ethos Treatment Planning, Ethos Radiotherapy System, Halcyon |
02/10/2020 |
K131807 |
VARIAN MEDICAL SYSTEMS, INC. |
HIGH ENERGY LINEAR ACCELERATOR |
10/11/2013 |
K192968 |
Varian Medical Systems, Inc. |
IDENTIFY |
11/12/2019 |
K123788 |
VARIAN MEDICAL SYSTEMS, INC. |
INTEGRATED COLLIMATOR VERIFICATION AND INTERLOCK SYSTEM (ICVI) |
01/15/2013 |
K203669 |
Varian Medical Systems, Inc. |
Mobius3D |
01/14/2021 |
K041519 |
VARIAN MEDICAL SYSTEMS, INC. |
MODIFICATION TO: ON-BOARD IMAGER DEVICE |
08/04/2004 |
K040192 |
VARIAN MEDICAL SYSTEMS, INC. |
ON-BOARD IMAGER DEVICE |
02/27/2004 |
K071360 |
VARIAN MEDICAL SYSTEMS, INC. |
OPTICAL GUIDANCE PLATFORM |
06/08/2007 |
K152761 |
VARIAN MEDICAL SYSTEMS, INC. |
Permanent Beacon Transponder, Soft Tissue Beacon Transponder, Beacon Care Package - Soft Tissue (17G) |
11/25/2015 |
K140823 |
VARIAN MEDICAL SYSTEMS, INC. |
PERMANENT BEACON TRANSPONDER/SOFT TISSUE BEACON TRANSPONDER |
06/27/2014 |
K003636 |
VARIAN MEDICAL SYSTEMS, INC. |
PORTALVISION |
02/02/2001 |
K091209 |
VARIAN MEDICAL SYSTEMS, INC. |
PORTALVISION ADVANCED IMAGING |
06/23/2009 |
K063270 |
VARIAN MEDICAL SYSTEMS, INC. |
RPM RESPIRATORY GATING SYSTEM |
12/14/2006 |
K133227 |
VARIAN MEDICAL SYSTEMS, INC. |
SMART SEGMENTATION - KNOWLEDGE BASED CONTOURING |
03/14/2014 |
K092871 |
VARIAN MEDICAL SYSTEMS, INC. |
TRILOGY MX |
11/30/2009 |
K033343 |
VARIAN MEDICAL SYSTEMS, INC. |
TRILOGY RADIOTHERAPY DELIVERY SYSTEM |
12/23/2003 |
K070094 |
VARIAN MEDICAL SYSTEMS, INC. |
TRILOGY RADIOTHERAPY DELIVERY SYSTEM AND TRILOGY TX DELIVERY SYSTEM |
02/09/2007 |
K072916 |
VARIAN MEDICAL SYSTEMS, INC. |
TRILOGY SYSTEM WITH RAPIDARC |
11/09/2007 |
K062618 |
VARIAN MEDICAL SYSTEMS, INC. |
TRILOGY TX WITH 3RD PARTY COUCH TOP SUPPORT |
09/22/2006 |
K081188 |
VARIAN MEDICAL SYSTEMS, INC. |
TRILOGY WITH EXTERNAL SYSTEM GATING INTERFACE |
07/14/2008 |
K111106 |
VARIAN MEDICAL SYSTEMS, INC. |
TRUEBEAM |
08/18/2011 |
K123291 |
VARIAN MEDICAL SYSTEMS, INC. |
TRUEBEAM |
12/20/2012 |
K143224 |
Varian Medical Systems, Inc. |
TrueBeam-TrueBeam STx-Edge |
12/19/2014 |
K162472 |
Varian Medical Systems, Inc. |
TrueBeam-TrueBeam STx-Edge |
01/19/2017 |
K171733 |
Varian Medical Systems, Inc. |
TrueBeam, TrueBeam STx, Edge |
07/12/2017 |
K231317 |
Varian Medical Systems, Inc. |
TrueBeam, TrueBeam STx, Edge, VitalBeam |
09/12/2023 |
K213977 |
Varian Medical Systems, Inc. |
TrueBeam, TrueBeam STx, Edge, VitalBeam |
06/03/2022 |
K223839 |
Varian Medical Systems, Inc. |
TrueBeam, TrueBeam STx, Edge, VitalBeam |
05/22/2023 |
K132705 |
VARIAN MEDICAL SYSTEMS, INC. |
UNIQUE |
10/31/2013 |
K180586 |
Varian Medical Systems, Inc. |
Varian Head Frame |
04/02/2018 |
K142560 |
VARIAN MEDICAL SYSTEMS, INC. |
Varian Head Frame |
12/11/2014 |
K162476 |
Varian Medical Systems, Inc. |
Varian High Energy Linear Accelerator |
12/12/2016 |
K181404 |
Varian Medical Systems, Inc. |
Varian High Energy Linear Accelerator, UNIQUE, Varian Multileaf Collimator |
06/28/2018 |
K133240 |
VARIAN MEDICAL SYSTEMS, INC. |
VARIAN MULTILEAF COLLIMATOR |
01/31/2014 |
K973889 |
VARIAN MEDICAL SYSTEMS, INC. |
VARIAN MULTILEAF COLLIMATOR WITH DYNAMIC ARC THERAPY FEATURE |
11/21/1997 |
K093967 |
VARIAN MEDICAL SYSTEMS, INC. |
VARIAN TREATMENT |
07/12/2010 |
K151882 |
VARIAN MEDICAL SYSTEMS, INC. |
Varian Treatment (VTx) |
10/26/2015 |
K142268 |
VARIAN MEDICAL SYSTEMS, INC. |
Varian Verification System (VVS) |
10/02/2014 |
K001643 |
VARIAN MEDICAL SYSTEMS, INC. |
VARIS 1.4G |
06/23/2000 |
K042956 |
VARIAN MEDICAL SYSTEMS, INC. |
VISION |
03/11/2005 |
K150706 |
VARIAN MEDICAL SYSTEMS, INC. |
VitalBeam |
05/08/2015 |
K172013 |
Varian Medical Systems, Inc. |
VitalBeam |
07/28/2017 |
K103394 |
VARIAN MEDICAL SYSTEMS, ONCOLOGY SYSTEMS |
BARCODE CONICAL COLLIMATOR VERIFICATION (BCCV) |
01/12/2011 |
K101751 |
VARIAN MEDICAL SYSTEMS, ONCOLOGY SYSTEMS |
VARIAN UNIQUE SINGLE ENERGY LINEAR ACCELERATOR |
08/10/2010 |
K971382 |
VICTOREEN, INC. |
PRONE BREAST POSITIONING BOARD, MODEL #37-018 |
06/06/1997 |
K964785 |
VICTOREEN, INC. |
VERIDOSE DIODES |
06/13/1997 |
K170751 |
ViewRay Incorporated |
MRIdian Linac System with 138-leaf Collimator |
06/07/2017 |
K162393 |
VIEWRAY INCORPORATED |
The ViewRay (MRIdian) Linac System |
02/24/2017 |
K111862 |
VIEWRAY INCORPORATED |
VIEWRAY SYSTEM |
05/22/2012 |
K181989 |
ViewRay, Incorporated |
MRIdian Linac System |
02/20/2019 |
K212958 |
ViewRay, Incorporated |
MRIdian Linac System |
12/14/2021 |
K190155 |
Viscus Biologics, LLC |
FibermarX Radiopaque Tissue Marker |
02/27/2019 |
K052682 |
VISION RT LIMITED |
ALIGNRT |
01/06/2006 |
K123371 |
VISION RT LIMITED |
ALIGNRT PLUS |
01/08/2013 |
K072171 |
VISION RT LIMITED |
GATECT-RT |
10/01/2007 |
K181218 |
Vision RT Ltd |
AlignRT Plus |
08/07/2018 |
K193431 |
Vision RT Ltd |
AlignRT Plus |
01/03/2020 |
K203387 |
Vision RT Ltd |
AlignRT Plus |
03/04/2021 |
K212583 |
Vision RT Ltd |
AlignRT Plus |
11/10/2021 |
K231185 |
Vision RT Ltd |
MapRT |
06/23/2023 |
K031634 |
WELLHOFER DOSIMETRIE |
OMNIPRO I'MRT |
08/29/2003 |
K032594 |
WELLHOFER DOSIMETRIE |
ONE DIMENSIONAL WATER PHANTOM, WP 1D |
09/05/2003 |
K032156 |
WFR/AQUAPLAST CORP. |
ACCUFIX RADIOLUCENT PELVIS AND BELLY BOARDS, ACCUFIX CANTILEVER HEAD BOARD WITH SHOULDER DEPRESSION, ACCUFIX RADIOLUCENT |
09/02/2003 |
K021124 |
WFR/AQUAPLAST CORP. |
ACCUFIX TILTING RADIOTRANSLUCENT HEADHOLDER |
07/02/2002 |
K171804 |
Zap Surgical Systems |
Zap-X Radiosurgery System |
09/21/2017 |
K183698 |
Zap Surgical Systems |
Zap-X Radiosurgery System |
02/25/2019 |
K211663 |
Zap Surgical Systems, Inc. |
Zap-X Radiosurgical System |
07/29/2021 |
K162002 |
ZDi, Solutions, LLC |
Z-Box/Z-Tilt Breast and Thoracic Positioning Device, Z-Square Indexing System, Z-Foam, Z-Bar Index Bar, Z-Pulls Patient Hand Grip Overlay |
11/01/2016 |