FDA 510(k) Applications Submitted by Varian Medical Systems, Inc.

FDA 510(k) Number Submission Date Device Name Applicant
K242874 09/23/2024 Gating Reflector Block Varian Medical Systems, Inc.
K980590 02/17/1998 VARISOURCE HENSCHKE TYPE GYN APPLICATOR FOR VARIAN VARISOURCE REMOTE HIGH DOSE RATE AFTERLOADER VARIAN MEDICAL SYSTEMS, INC.
K971839 05/19/1997 VARIAN RADIATION THERAPY IMAGING SYSTEM VARIAN MEDICAL SYSTEMS, INC.
K962950 07/29/1996 CADPLAN, VERSION 2.62. RADIATION THERAPY TREATMENT PLANNING SYSTEM VARIAN MEDICAL SYSTEMS, INC.
K973889 10/14/1997 VARIAN MULTILEAF COLLIMATOR WITH DYNAMIC ARC THERAPY FEATURE VARIAN MEDICAL SYSTEMS, INC.
K964138 10/15/1996 VARIAN XIMATRON C-SERIES RADIATION THERAPY SIMULATOR WITH VERSION 4.2 SOFTWARE VARIAN MEDICAL SYSTEMS, INC.
K980576 02/17/1998 VARIAN ENDOMETRIAL APPLICATOR FOR VARISOURCE REMOTE HIGH DOSE RATE AFTERLOADER VARIAN MEDICAL SYSTEMS, INC.
K010975 04/02/2001 ECLIPSE 6.5 VARIAN MEDICAL SYSTEMS, INC.
K981056 03/23/1998 VARIAN XIMATRON SCAN VISION CT VARIAN MEDICAL SYSTEMS, INC.
K021268 04/22/2002 ECLIPSE, HELIOS OPTION VARIAN MEDICAL SYSTEMS, INC.
K001643 05/30/2000 VARIS 1.4G VARIAN MEDICAL SYSTEMS, INC.
K002194 07/20/2000 TREATVISION VARIAN MEDICAL SYSTEMS, INC.
K002312 07/31/2000 PROTON VISION 7.0 VARIAN MEDICAL SYSTEMS, INC.
K023052 09/13/2002 ACUITY RADIATION THERAPY SIMULATOR VARIAN MEDICAL SYSTEMS, INC.
K983629 10/15/1998 RPM RESPIRATORY GATING SYSTEM VARIAN MEDICAL SYSTEMS, INC.
K003636 11/24/2000 PORTALVISION VARIAN MEDICAL SYSTEMS, INC.
K024147 12/16/2002 PAXSCAN 4030 MEDICAL DIGITAL IMAGING SYSTEM VARIAN MEDICAL SYSTEMS, INC.
K984532 12/21/1998 CADPLAN HELIOS OPTION 6.0 VARIAN MEDICAL SYSTEMS, INC.
K140823 04/01/2014 PERMANENT BEACON TRANSPONDER/SOFT TISSUE BEACON TRANSPONDER VARIAN MEDICAL SYSTEMS, INC.
K250299 01/31/2025 CT/ MR Tandem and Ovoid Set Varian Medical Systems, Inc.
K240480 02/20/2024 IntelliBlate Microwave Ablation System Console (IB-CON); IntelliBlate Microwave Ablation System Mobile Cart (IB-CART); IntelliBlate Ximitry Probe Assembly, 13G x 15cm (IB-XPA-1315); IntelliBlate Ximitry Probe Assembly, 13G x 20cm (IB-XPA-1320); IntelliBla Varian Medical Systems, Inc.
K240784 03/21/2024 Temperature Sensor Probe (ABL-18TP20) Varian Medical Systems, Inc.
K241386 05/15/2024 Heyman Packing Applicator Set (GM11004580) Varian Medical Systems, Inc.
K241764 06/20/2024 Mould Probe MR Safe Varian Medical Systems, Inc.
K241853 06/27/2024 Titanium Fletcher-Style Applicator Set Defined Geometry; Smit Cervical Sleeve Varian Medical Systems, Inc.
K242608 09/03/2024 Embozene Color-Advanced Microspheres Varian Medical Systems, Inc.
K242794 09/16/2024 ONCOZENE Microspheres Varian Medical Systems, Inc.
K242957 09/25/2024 Identify (4.0) Varian Medical Systems, Inc.
K243939 12/20/2024 Titanium Flexible Geometry FSD Applicator Set (GM11013400) Varian Medical Systems, Inc.
K152761 09/24/2015 Permanent Beacon Transponder, Soft Tissue Beacon Transponder, Beacon Care Package - Soft Tissue (17G) VARIAN MEDICAL SYSTEMS, INC.
K211881 06/21/2021 AI Segmentation Varian Medical Systems, Inc.
K231863 06/23/2023 ProBeam 360░ Proton Therapy System v2.0 (Multiroom) Varian Medical Systems, Inc.
K203469 11/25/2020 AI Segmentation Varian Medical Systems, Inc.
K161540 06/03/2016 Advanced Breast Template System VARIAN MEDICAL SYSTEMS, INC.
K230271 01/31/2023 ISOLIS Cryoprobe Varian Medical Systems, Inc.
K130251 02/01/2013 ESOPHAGUS BOUGIE SET VARIAN MEDICAL SYSTEMS, INC.
K141248 05/14/2014 SMART SEGMENTATION KNOWLEDGE BASED CONTOURING VARIAN MEDICAL SYSTEMS, INC.
K141283 05/16/2014 ECLIPSE TREATMENT PLANNING SYSTEM VARIAN MEDICAL SYSTEMS, INC.
K141336 05/21/2014 SOURCE GUIDE TUBE WITH LOCKING MECHANISM FOR 113 MM NEEDLES, GAMMAMEDPLUS VARIAN MEDICAL SYSTEMS, INC.
K141490 06/05/2014 UNIVERSAL SEGMENTED CYLINDER APPLICATOR SET AND UNIVERSAL STUMP APPLICATOR SET VARIAN MEDICAL SYSTEMS, INC.
K141624 06/17/2014 PLASTIC NEEDLE WITH MANDRIN, 2.0 MM DIAMETER, LENGTH, BLUNT TIP,PLASTIC NEEDLE WITH MANDRIN, 2.0 MM DIAMETER, LENGTH 113 VARIAN MEDICAL SYSTEMS, INC.
K131807 06/19/2013 HIGH ENERGY LINEAR ACCELERATOR VARIAN MEDICAL SYSTEMS, INC.
K131891 06/25/2013 ECLIPSE TREATMENT PLANNING SYSTEM VARIAN MEDICAL SYSTEMS, INC.
K132705 08/29/2013 UNIQUE VARIAN MEDICAL SYSTEMS, INC.
K192377 08/30/2019 Ethos Treatment Management, Ethos Treatment Planning, Ethos Radiotherapy System, Halcyon Varian Medical Systems, Inc.
K142560 09/11/2014 Varian Head Frame VARIAN MEDICAL SYSTEMS, INC.
K133227 10/21/2013 SMART SEGMENTATION - KNOWLEDGE BASED CONTOURING VARIAN MEDICAL SYSTEMS, INC.
K133240 10/21/2013 VARIAN MULTILEAF COLLIMATOR VARIAN MEDICAL SYSTEMS, INC.
K133247 10/22/2013 ECLIPSE TREATMENT PLANNING SYSTEM VARIAN MEDICAL SYSTEMS, INC.
K192968 10/23/2019 IDENTIFY Varian Medical Systems, Inc.
K133331 10/29/2013 4D INTEGRATED TREATMENT CONSOLE VARIAN MEDICAL SYSTEMS, INC.
K133572 11/20/2013 ARIA RADIATION THERAPY MANAGEMENT VARIAN MEDICAL SYSTEMS, INC.
K123788 12/10/2012 INTEGRATED COLLIMATOR VERIFICATION AND INTERLOCK SYSTEM (ICVI) VARIAN MEDICAL SYSTEMS, INC.
K123815 12/12/2012 SURFACE APPLICATOR SET WITH LEIPZIG-STYLE CONE VARIAN MEDICAL SYSTEMS, INC.
K160021 01/05/2016 Varian Sterilization Boxes VARIAN MEDICAL SYSTEMS, INC.
K230557 02/28/2023 Eclipse Treatment Planning System (v18.0) Varian Medical Systems, Inc.
K180586 03/05/2018 Varian Head Frame Varian Medical Systems, Inc.
K200608 03/09/2020 Eclipse Treatment Planning System v16.0 Varian Medical Systems, Inc.
K150636 03/11/2015 VariSeed 9.0 VARIAN MEDICAL SYSTEMS, INC.
K150706 03/18/2015 VitalBeam VARIAN MEDICAL SYSTEMS, INC.
K160815 03/24/2016 Interstitial Needles VARIAN MEDICAL SYSTEMS, INC.
K150839 03/30/2015 3D Interstitial Ring Applicator Set 60, 3D Interstitial Ring Applicator Set 90, Ring Applicator Set 45, Ring Applicator Set 60, Ring Applicator Set 90 VARIAN MEDICAL SYSTEMS, INC.
K170969 03/31/2017 Eclipse Treatment Planning System Varian Medical Systems, Inc.
K151022 04/16/2015 Intraluminal Applicator Set VARIAN MEDICAL SYSTEMS, INC.
K211149 04/19/2021 Urethral Warming Catheter Kit Varian Medical Systems, Inc.
K181145 05/01/2018 Eclipse Treatment Planning System Varian Medical Systems, Inc.
K231317 05/08/2023 TrueBeam, TrueBeam STx, Edge, VitalBeam Varian Medical Systems, Inc.
K181404 05/29/2018 Varian High Energy Linear Accelerator, UNIQUE, Varian Multileaf Collimator Varian Medical Systems, Inc.
K171631 06/02/2017 Standard Catheter Set Varian Medical Systems, Inc.
K161576 06/07/2016 Esophagus Bougie Set Varian Medical Systems, Inc.
K201588 06/12/2020 CRYOCARE TOUCH System and Accessories, Endocare 1.7mm Round Ice PerCryo Cryoprobe, Short, Round Ice Varian Medical Systems, Inc.
K191580 06/14/2019 BRAVOS Afterloader System, Transfer Guide Tubes, Length Assessment Device Varian Medical Systems, Inc.
K221791 06/21/2022 ProBeam 360░ Proton Therapy System Varian Medical Systems, Inc.
K172013 07/03/2017 VitalBeam Varian Medical Systems, Inc.
K151882 07/09/2015 Varian Treatment (VTx) VARIAN MEDICAL SYSTEMS, INC.
K162018 07/14/2016 Surface Applicator Set Varian Medical Systems, Inc.
K181903 07/16/2018 BRAVOS Afterloader Family: BRAVOS Afterloader System, Transfer Guide Tubes, and Length Assessment Device Varian Medical Systems, Inc.
K172163 07/18/2017 Eclipse Treatment Planning System Varian Medical Systems, Inc.
K152018 07/21/2015 Varian Cleaning Caps, Varian Leak Stop Buttons, Varian Leak Stop Channel Marker Sets VARIAN MEDICAL SYSTEMS, INC.
K212294 07/22/2021 Ethos Treatment Management, Ethos Treatment Planning Varian Medical Systems, Inc.
K142268 08/15/2014 Varian Verification System (VVS) VARIAN MEDICAL SYSTEMS, INC.
K172533 08/22/2017 GM Implant Tubes, Length Cutting Gauge Varian Medical Systems, Inc.
K152393 08/24/2015 Eclipse Treatment Planning System VARIAN MEDICAL SYSTEMS, INC.
K172675 09/05/2017 Varian Cervical Sleeves Varian Medical Systems, Inc.
K162472 09/06/2016 TrueBeam-TrueBeam STx-Edge Varian Medical Systems, Inc.
K162476 09/06/2016 Varian High Energy Linear Accelerator Varian Medical Systems, Inc.
K143224 11/10/2014 TrueBeam-TrueBeam STx-Edge Varian Medical Systems, Inc.
K173636 11/24/2017 Velocity Varian Medical Systems, Inc.
K193240 11/25/2019 Universal Cylinder Applicator Family Varian Medical Systems, Inc.
K203669 12/16/2020 Mobius3D Varian Medical Systems, Inc.
K213927 12/16/2021 Respiratory Gating for Scanners v2.0 Varian Medical Systems, Inc.
K173838 12/18/2017 ARIA Radiation Therapy Management Varian Medical Systems, Inc.
K213977 12/20/2021 TrueBeam, TrueBeam STx, Edge, VitalBeam Varian Medical Systems, Inc.
K223839 12/22/2022 TrueBeam, TrueBeam STx, Edge, VitalBeam Varian Medical Systems, Inc.
K203766 12/23/2020 4D Integrated Treatment Console Varian Medical Systems, Inc.
K171733 06/12/2017 TrueBeam, TrueBeam STx, Edge Varian Medical Systems, Inc.
K070094 01/10/2007 TRILOGY RADIOTHERAPY DELIVERY SYSTEM AND TRILOGY TX DELIVERY SYSTEM VARIAN MEDICAL SYSTEMS, INC.
K040192 01/28/2004 ON-BOARD IMAGER DEVICE VARIAN MEDICAL SYSTEMS, INC.
K120341 02/03/2012 PLASTIC NEEDLE WITH MANDRIN 2.0 DIAMETER LENGTH 113MM VARIAN MEDICAL SYSTEMS, INC.
K040541 03/02/2004 MAMMOSOURCE HIGH DOSE RATE (HDR) REMOTE AFTERLOADER VARIAN MEDICAL SYSTEMS, INC.
K120731 03/09/2012 TITANIUM FLETCHER-STYLE APPLICATOR SET-DEFINED GEOMETRY VARIAN MEDICAL SYSTEMS, INC.
K030981 03/28/2003 ECLIPSE VARIAN MEDICAL SYSTEMS, INC.
K120993 04/02/2012 GAMMAMEDPLUS IX BRACHYTHERAPY AFTERLOADER, GAMMAMEDPLUS 3/24 IX BRACHYTHERAPY AFTERLOADER VARIAN MEDICAL SYSTEMS, INC.
K081036 04/11/2008 4D INTEGRATED TREATMENT CONSOLE WITH PATIENT ACCESSORY VERIFICATION SYSTEM (PAVS) VARIAN MEDICAL SYSTEMS, INC.
K111106 04/20/2011 TRUEBEAM VARIAN MEDICAL SYSTEMS, INC.
K091209 04/24/2009 PORTALVISION ADVANCED IMAGING VARIAN MEDICAL SYSTEMS, INC.
K081188 04/28/2008 TRILOGY WITH EXTERNAL SYSTEM GATING INTERFACE VARIAN MEDICAL SYSTEMS, INC.
K031524 05/15/2003 GAMMAMED PLUS 3/24 HDR REMOTE AFTERLOADER VARIAN MEDICAL SYSTEMS, INC.
K071360 05/15/2007 OPTICAL GUIDANCE PLATFORM VARIAN MEDICAL SYSTEMS, INC.
K091492 05/20/2009 MODIFICATION TO ECLIPSE TREATMENT PLANNING SYSTEM VARIAN MEDICAL SYSTEMS, INC.
K071467 05/29/2007 VARISOURCE IX HDR AFTERLOADER VARIAN MEDICAL SYSTEMS, INC.
K051497 06/06/2005 VITESSE 2.0 VARIAN MEDICAL SYSTEMS, INC.
K041519 06/07/2004 MODIFICATION TO: ON-BOARD IMAGER DEVICE VARIAN MEDICAL SYSTEMS, INC.
K061582 06/07/2006 VARISOURCE 200 HDR AFTERLOADER VARIAN MEDICAL SYSTEMS, INC.
K071760 06/29/2007 MODIFICATION TO: ECLIPSE TREATMENT PLANNING SYSTEM VARIAN MEDICAL SYSTEMS, INC.
K071873 07/06/2007 MODIFICATION TO ECLIPSE TREATMENT PLANNING SYSTEM VARIAN MEDICAL SYSTEMS, INC.
K102011 07/16/2010 ECLIPSE TREATMENT PLANNING SYSTEM VARIAN MEDICAL SYSTEMS, INC.
K122236 07/26/2012 VARISOURSE IX BRAHYTHERAPY AFTERLOADER VARISOURCE IX (T) BRACHYTHERAPY AFTERLOADER VARIAN MEDICAL SYSTEMS, INC.
K042360 08/31/2004 VARIAN NASOPHARYNX APPLICATOR VARIAN MEDICAL SYSTEMS, INC.
K062618 09/05/2006 TRILOGY TX WITH 3RD PARTY COUCH TOP SUPPORT VARIAN MEDICAL SYSTEMS, INC.
K082653 09/12/2008 CENTERING INTRALUMINAL APPLICATOR VARIAN MEDICAL SYSTEMS, INC.
K092871 09/18/2009 TRILOGY MX VARIAN MEDICAL SYSTEMS, INC.
K072916 10/12/2007 TRILOGY SYSTEM WITH RAPIDARC VARIAN MEDICAL SYSTEMS, INC.
K033343 10/17/2003 TRILOGY RADIOTHERAPY DELIVERY SYSTEM VARIAN MEDICAL SYSTEMS, INC.
K033339 10/17/2003 ACUITY WITH CONEBEAM COMPUTED TOMOGRAPHY VARIAN MEDICAL SYSTEMS, INC.
K093291 10/21/2009 VARIAN INTERSTITIAL TITANIUM NEEDLES VARIAN MEDICAL SYSTEMS, INC.
K123291 10/22/2012 TRUEBEAM VARIAN MEDICAL SYSTEMS, INC.
K073020 10/26/2007 ECLIPSE TREATMENT PLANNING SYSTEM VARIAN MEDICAL SYSTEMS, INC.
K042956 10/27/2004 VISION VARIAN MEDICAL SYSTEMS, INC.
K063270 10/30/2006 RPM RESPIRATORY GATING SYSTEM VARIAN MEDICAL SYSTEMS, INC.
K073133 11/07/2007 INTERSTITIAL NEEDLES VARIAN MEDICAL SYSTEMS, INC.
K093527 11/16/2009 ARIA RADIATION ONCOLOGY WITH MIRS VARIAN MEDICAL SYSTEMS, INC.
K113766 12/21/2011 CLICKFIT TRANSFER GUIDE TUBES NEEDLE CLICKFIT TRANSFER GUIDE TUBES CATHETER TRANSFER GUIDE TUBE SET VARISOURCE LUER TRAN VARIAN MEDICAL SYSTEMS, INC.
K093967 12/23/2009 VARIAN TREATMENT VARIAN MEDICAL SYSTEMS, INC.


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