FDA 510(k) Applications for Medical Device Product Code "KPR"
(System, X-Ray, Stationary)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K101042 | ACCOGENT LLC | BLADEVIEW | 10/29/2010 |
| K200944 | Adani | UNIEXPERT 2 PLUS | 05/26/2020 |
| K974863 | ADVANCED INSTRUMENT DEVELOPMENT, INC. | IMIX DIGITAL THORAX SYSTEM | 03/17/1998 |
| K122119 | AFGA HEALTHCARE N.V. | DX-D FULL LEG FULL SPINE | 09/13/2012 |
| K103050 | AGFA HEALTHCARE N.V. | DX-D 300 | 10/29/2010 |
| K112670 | AGFA HEALTHCARE N.V. | DX-D 600 | 10/27/2011 |
| K162529 | Allengers Medical Systems Limited | DigiX FDX | 03/03/2017 |
| K192541 | Allengers Medical Systems Limited | DigiX FDX | 10/16/2019 |
| K223060 | Allengers Medical Systems Limited | DigiX FDX | 10/26/2022 |
| K080614 | ALMANA MEDICAL IMAGING | DR VISION NEO, DR VISION DOU | 06/20/2008 |
| K072659 | ALMANA MEDICAL IMAGING | RAD VISION, MODELS E AND EU | 11/15/2007 |
| K082064 | ALMANA MEDICAL IMAGING | RADVISION ET DIAGNOSTIC X-RAY SYSTEM | 08/22/2008 |
| K033345 | ANALOGIC CORP. | AN5150 AND AN7150 DIGITAL RADIOLOGY SYSTEMS | 11/19/2003 |
| K001341 | ANALOGIC CORP. | DR5000 DEDICATED CHEST X-RAY SYSTEM | 06/02/2000 |
| K001336 | ANALOGIC CORP. | DR9000 DIGITAL RADIOGRAPHY X-RAY SYSTEM | 06/02/2000 |
| K040995 | ANALOGIC CORP. | SYNERAD MULTI DIGITAL X-RAY SYSTEM, MODEL AN6150 | 05/25/2004 |
| K043025 | ANALOGIC CORP. | SYNERAD OMNI, DIGITAL X-RAY SYSTEM, MODEL AN6250 | 11/19/2004 |
| K071430 | ANALOGIC CORP. | SYNERAD OMNI, MODELS AN6255 AND AN6265 | 06/21/2007 |
| K140683 | ARCOMA AB | 0180 INTUITION, 0072 PRECISION | 06/03/2014 |
| K073632 | ARCOMA AB | INTUITION, MODEL 0170 | 01/10/2008 |
| K160857 | ARQUILLA, INC. DBA X-CEL X-RAY CORPORATION | HF 718BD X-Ray System | 02/24/2017 |
| K052541 | AVANT MEDICAL SYSTEMS | MODEL HF-50R COMPUTER CONTROLLED X-RAY SYSTEM | 11/03/2005 |
| K974597 | BAYER CORP., AGFA DIV. | ADC COMPACT (AGFA DIAGNOSTIC CENTER) | 03/09/1998 |
| K151219 | BEIJING POLYCON MEDICAL ENGINEERING COMPANY | Models 2200DR and 1600DR Digital Stationary Radiographic Systems | 08/04/2015 |
| K121854 | BEIJING SINOPHARM HUNDRIC MEDILINE INFO. TECH. CO. | SYSTEM, X-RAY, STATIONARY | 08/22/2012 |
| K071546 | BIOSPACE MED | EOS | 09/18/2007 |
| K201373 | Carestream Health, Inc | DRX-Compass | 06/26/2020 |
| K163203 | Carestream Health, Inc. | Carestream DRX-Evolution | 12/13/2016 |
| K223842 | Carestream Health, Inc. | DRX - Compass | 01/20/2023 |
| K191879 | Carestream Health, Inc. | DRX-Evolution with Carestream Digital Tomosynthesis | 12/20/2019 |
| K091889 | CARESTREAM HEALTH, INC. | DRX-EVOLUTION, MODEL VX3733-SYS | 07/20/2009 |
| K190330 | Carestream Health, Inc. | DRX-Evolution/Plus with Dual Energy | 11/04/2019 |
| K193574 | Carestream Health, Inc. | Q-Rad System | 01/22/2020 |
| K081836 | CARESTREAM HEALTH,INC. | CARESTREAM DR LONG LENGTH IMAGING SYSTEM FOR DR 7500 SYSTEM | 07/30/2008 |
| K141837 | CARESTREAM HEALTH,INC. | DRX-EVOLUTION | 03/11/2015 |
| K083640 | CHOONGWAE MEDICAL CORP. | DIGITAL X-RAY IMAGING SYSTEM, MODEL: CXD-DR80D | 06/29/2009 |
| K162224 | CMT MEDICAL TECHNOLOGIES, LTD. | ArtPix Mobile EZ2GO | 09/22/2016 |
| K110849 | CMT MEDICAL TECHNOLOGIES, LTD. | PRESTODR 4143 | 04/26/2011 |
| K122726 | COMMUNICATIONS & POWER INDUSTRIES CANADA, INC. | CPI RAD VISION | 02/15/2013 |
| K182134 | Compania Mexicana De Radiologia CGR, S.A. DE C.V. | ARiX RAD Radiographic System | 11/26/2018 |
| K193637 | Compania Mexicana De Radiologia CGR, S.A. DE C.V. | MRH ALFA Radiographic System, MRH II Radiographic System, MRH IIE Radiographic System | 01/28/2020 |
| K102680 | CONTROL-X MEDICAL, INC. | Z-MOTION DIGITAL DIAGNOSTIC X-RAY SYSTEM | 10/22/2010 |
| K161937 | Cuattro, LLC | CuattroDR | 10/06/2016 |
| K223550 | Del Medical, Inc. | DMX | 04/10/2023 |
| K152767 | DEL MEDICAL, INC. | OTC12D AUTO RADIOGRAPHIC SYSTEM | 12/14/2015 |
| K192453 | DRGEM Corporation | DIAMOND-5A/6A/8A | 10/01/2019 |
| K202156 | DRGEM Corporation | DIAMOND-5A/6A/8A | 09/10/2020 |
| K102408 | DRGEM CORPORATION | DIGITAL DIAGNOSTIC X-RAY SYSTEM | 12/27/2010 |
| K232178 | DRGEM Corporation | GXR-ES/ECS Diagnostic X-Ray System, (Models GXR-ES series, GXR-ECS series) | 09/19/2023 |
| K192364 | DRGEM Corporation | GXR-Series Diagnostic X-Ray System | 09/26/2019 |
| K202572 | DRGEM Corporation | GXR-Series Diagnostic X-Ray System | 09/24/2020 |
| K091747 | DRTECH CORP. | FLAATZ 500 | 07/01/2009 |
| K111655 | DRTECH CORP. | FLAATZ 760 | 11/30/2011 |
| K082261 | DXRAD SOLUTIONS LTD. | DXRAD MODELS DX800 OR DX808 DIGITAL DIAGNOSTIC RADIOGRAPHIC SYSTEMS | 11/06/2008 |
| K962896 | EASTMAN KODAK COMPANY | KODAK DIGITAL SCIENCE REMOTE CASSETTE | 09/20/1996 |
| K060550 | EASTMAN KODAK COMPANY | KODAK DIRECTVIEW DR 3000 SYSTEM 64KW/80KW GENERATORS, MODELS 6551345, 6551386 | 03/31/2006 |
| K051258 | EASTMAN KODAK COMPANY | KODAK DIRECTVIEW DR 7500 SYSTEM, MODEL 8791345 | 06/01/2005 |
| K152788 | EOS IMAGING | EOS System | 10/21/2015 |
| K142773 | EOS IMAGING | EOS System | 01/22/2015 |
| K192079 | EOS imaging | EOSedge | 11/27/2019 |
| K202394 | EOS imaging | EOSedge | 09/16/2020 |
| K101686 | FUJIFILM MEDICAL SYSTEM U.S.A., INC. | FDR IMAGE STITCHING OPTION | 10/29/2010 |
| K122454 | FUJIFILM MEDICAL SYSTEM U.S.A., INC. | FUJIFILM DUAL ENERGY SUBTRACTION (DES) SOFTWARE OPTION | 11/20/2012 |
| K073650 | FUJIFILM MEDICAL SYSTEMS USA, INC. | FUJIFILM UNITY SPEEDSUITE, MODEL CR-IR 371 | 02/06/2008 |
| K051967 | GE HEALTHCARE | REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM WITH TOMOSYNTHESIS | 08/09/2005 |
| K143270 | GE HUALUN MEDICAL SYSTEMS CO. LTD | Optima XR646 | 02/18/2015 |
| K231892 | GE Hualun Medical Systems Co. Ltd. | Definium Pace Select | 09/12/2023 |
| K191699 | GE Hualun Medical Systems Co., Ltd | Discovery XR656 HD with VolumeRad | 07/24/2019 |
| K173612 | GE Hualun Medical Systems Co., Ltd | Optima XR646 HD | 12/11/2017 |
| K172869 | GE Hualun Medical Systems Co.Ltd. | Discovery XR656 HD | 10/20/2017 |
| K982196 | GE MEDICAL SYSTEMS | DIGITAL RADIOGRAPHIC IMAGING SYSTEM | 10/06/1998 |
| K013481 | GE MEDICAL SYSTEMS | DUAL ENERGY AND TISSUE EQUALIZATION SOFTWARE OPTION | 11/02/2001 |
| K992066 | GE MEDICAL SYSTEMS | REVOLUTION TX/I DIGITAL RADIOGRAPHIC TABLE SYSTEM | 08/30/1999 |
| K982955 | GE MEDICAL SYSTEMS | SILHOUETTE VR | 11/04/1998 |
| K993665 | GE MEDICAL SYSTEMS, INC. | LEGEND CRF FLUORO AND RAD SYSTEM | 11/12/1999 |
| K012389 | GE MEDICAL SYSTEMS, INC. | REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM | 08/10/2001 |
| K993090 | GE MEDICAL SYSTEMS, INC. | SILHOUETTE FC | 10/01/1999 |
| K103448 | GE MEDICAL SYSTEMS, LLC | BRIVO XR385 | 08/12/2011 |
| K133695 | GEMSS MEDICAL SYSTEMS CO., LTD | TITAN 11 | 08/07/2014 |
| K050704 | GENERAL ELECTRIC CO. | MODIFICATION TO: REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM WITH IMAGE PASTING AND AUTOPOSITIONING | 04/08/2005 |
| K182880 | Halifax Biomedical, Inc. | Halifax Imaging Kit | 10/31/2018 |
| K121345 | HALIFAX BIOMEDICAL, INC. | SR SUITE 1.0 | 06/01/2012 |
| K022667 | HEALTH CARE MFG., INC. | HCMI X-RAY | 10/22/2002 |
| K022737 | HEALTH CARE MFG., INC. | HCMI X-RAY HIGH REQUENCY CHIROPRACTIC RADIOGRAPHIC | 10/22/2002 |
| K982824 | I.E.D., INC. | X-RAY TIMER MODEL I.E.D. 7888 I.D. 7881 AND B764ID | 10/29/1998 |
| K990242 | I.Z.I. MEDICAL PRODUCTS CORP. | TOPOGRAPHIC IMAGING MARKER | 03/03/1999 |
| K990298 | I.Z.I. MEDICAL PRODUCTS CORP. | TOPOGRAPHIC IMAGING MARKER | 03/03/1999 |
| K062634 | IMAGING DYNAMICS COMPANY LTD. | ORTHOXP | 10/06/2006 |
| K071408 | IMAGING DYNAMICS COMPANY LTD. | X3C 1100 RADIOGRAPHIC TABLE WITH DIGITAL RADIOGRAPHIC DETECTOR | 06/13/2007 |
| K071409 | IMAGING DYNAMICS COMPANY LTD. | X3C 1590 DIGITAL RADIOGRAPHIC SYSTEM | 06/08/2007 |
| K071403 | IMAGING DYNAMICS COMPANY LTD. | X3C 1600 DIGITAL RADIOGRAPHIC SYSTEM | 06/11/2007 |
| K071402 | IMAGING DYNAMICS COMPANY LTD. | X3C 1600 PLUS DIGITAL RADIOGRAPHIC SYSTEM | 06/08/2007 |
| K071401 | IMAGING DYNAMICS COMPANY LTD. | X3C 2200 DIGITAL RADIOGRAPHIC SYSTEM | 06/22/2007 |
| K061595 | IMAGING DYNAMICS COMPANY LTD. | XAMINER | 08/17/2006 |
| K062417 | IMAGING DYNAMICS COMPANY LTD. | XPLORER 1100 | 09/15/2006 |
| K063246 | IMAGING DYNAMICS COMPANY LTD. | XPLORER 1500 DIGITAL RADIOGRAPHIC SYSTEM WITH STAND | 11/22/2006 |
| K062405 | IMAGING DYNAMICS COMPANY LTD. | XPLORER 1590 | 09/13/2006 |
| K063247 | IMAGING DYNAMICS COMPANY LTD. | XPLORER 1800 DIGITAL RADIOGRAPHIC SYSTEM WITH UNIVERSAL STAND | 11/22/2006 |
| K092307 | IMASIGHT INC | IMASIGHT 4600 DIGITAL RADIOGRAPHY SENSOR | 08/25/2009 |
| K072867 | IMIX ADR FINLAND OY | IMIX 2000 DIGITAL RADIOGRAPHY SYSTEM, MODELS UNV 3K, UNV 3KW, UNV 4K | 11/21/2007 |
| K073114 | IMIX ADR FINLAND OY | IMIX INSIGHT X-RAY SYSTEMS | 01/17/2008 |
| K101435 | IMIX ADR FINLAND OY | IMIX PANORAD AND SOMARAD | 09/15/2010 |
| K113855 | IMIX ADR FINLAND OY | PANORAD, PANORAD SL | 01/25/2012 |
| K213057 | JPI Healthcare Co, Ltd. | ExamVue Duo | 02/18/2022 |
| K101779 | JPI HEALTHCARE CO., LTD | CLEARVISION DR 2000 DIGITAL RADIOGRAPHY X-RAY SYSTEM | 05/16/2011 |
| K142930 | JPI HEALTHCARE CO., LTD | Exam Vue DR | 04/17/2015 |
| K193225 | Konica Minolta Healthcare Americas, Inc | KDR AU-DDR System Advanced U-Arm with Dynamic Digital Radiography, KDR AU System Advanced U-Arm with Static Digital Radiography | 01/15/2020 |
| K221853 | Konica Minolta Healthcare Americas, Inc | OTC DDR | 07/27/2022 |
| K214012 | Konica Minolta Healthcare Americas, Inc | Straight Arm DDR | 01/12/2022 |
| K120752 | KONICA MINOLTA MEDICAL & GRAPHIC, INC. | AERODR STITCHING SYSTEM | 06/08/2012 |
| K102349 | KONICA MINOLTA MEDICAL & GRAPHIC, INC. | AERODR SYSTEM | 11/24/2010 |
| K113248 | KONICA MINOLTA MEDICAL & GRAPHIC, INC. | AERODR SYSTEM WITH P-21 | 01/17/2012 |
| K121109 | KONICA MINOLTA MEDICAL & GRAPHIC, INC. | AERODR X70 | 05/23/2012 |
| K083510 | KUB TECHNOLOGIES, INC | KUBTEC XPERT 20 | 01/08/2009 |
| K180663 | LIVERMORETECH Inc. | LaVid FMTS DIAGNOSTIC X-RAY SYSTEM | 05/18/2018 |
| K122589 | MDI CONSULTANTS, INC. | DFP4343C7 | 10/05/2012 |
| K082798 | MEDICATECH USA | DIGITAL DIAGNOSTIC X-RAY SYSTEM, MODELS MAK 1500, MAK 2000 AND MAK 3000 | 10/28/2008 |
| K102285 | MEDICATECH USA | KRYSTALRAD (ATAL8) | 01/03/2011 |
| K143257 | MEDICATECH USA | KrystalRad 11000 and KrystalRad 3000 Digital Stationary Radiographic System | 02/06/2015 |
| K102284 | MEDICATECH USA | KRYSTALRAD 560 (FLAATZ 560) | 01/03/2011 |
| K190601 | MedicaTech USA | MasteRad MX30 | 04/25/2019 |
| K080582 | MEDICATECH USA | MEDICATECH, MODEL DDR MAK-800, DDT MAK-1000 FS, DDR MAK-1100 FA | 05/15/2008 |
| K093816 | MEDIEN INTERNATIONAL CO., LTD | DIGITAL RADIOGRAPHY SYSTEM, MODELS GALAXY 900 AND 1600 | 10/05/2010 |
| K033577 | MEDLINK IMAGING | UNISCAN, PULMOSCAN, PULMOSCAN RADIOGRAPHIC SYSTEMS | 03/18/2005 |
| K080655 | META IMAGING SOLUTIONS, LLC | CHRYSALIS | 05/09/2008 |
| K011111 | MODULAR X-RAY DEVICES | MXD100/MX 20, OR MX 30, OR MX 40 OR MX 50--(MXD 100 SERIES) | 05/30/2001 |
| K220271 | NanoRay Biotech Co., Ltd | Hand Diagnostic Radiography Imaging System | 04/29/2022 |
| K012165 | NUCLETRON CORP. | OLDELFT THORASCAN MODEL NUMBER 180T | 09/19/2001 |
| K972766 | OCTOSTOP, INC. | PIVOTING COMPENSATING FILTERS FOR THE HEAD | 08/14/1997 |
| K963941 | OCTOSTOP, INC. | THE PHARAOH COMPENSATING FILTER | 11/27/1996 |
| K973219 | OLDELFT CORP. OF AMERICA | AMBER DU | 10/08/1997 |
| K980296 | OLDELFT CORP. OF AMERICA | OLDELFT DIGIDELCA | 04/17/1998 |
| K120034 | ORICH MEDICAL EQUIPMENT (TIANJIN CO., LTD. | RADIOGRAPHIC X-RAY SYSTEM | 04/17/2012 |
| K152813 | ORICH MEDICAL EQUIPMENT (TIANJIN) CO., LTD. | FS-500DDR Medical Radiographic X-Ray System | 12/02/2016 |
| K150663 | OSKO, INC. | Diagnostic X-ray System | 05/07/2015 |
| K150506 | OSKO, INC. | ELIAN Digital Diagnostic X-ray System | 04/08/2015 |
| K201725 | Philips Healthcare (Suzhou) Co., Lit. | DigitalDiagnost C50 | 07/10/2020 |
| K163410 | PHILIPS HEALTHCARE (SUZHOU) CO., LTD. | DigitalDiagnost C50 | 01/04/2017 |
| K141381 | PHILIPS HEALTHCARE (SUZHOU) CO., LTD. | DURADIAGNOST | 06/12/2014 |
| K201640 | Philips Healthcare (Suzhou) Co., Ltd. | DuraDiagnost | 07/09/2020 |
| K210692 | Philips Medical Systems DMC GmbH | DigitalDiagnost | 04/02/2021 |
| K212186 | Philips Medical Systems DMC GmbH | Philips Radiology Smart Assistant | 12/13/2021 |
| K031535 | PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO. | PHILIPS EASYDIAGNOST ELEVA | 06/17/2003 |
| K050151 | PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. | MULTIDIAGNOST ELEVA | 02/09/2005 |
| K981657 | PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. | PHILIPS THORAVISION | 06/18/1998 |
| K984111 | PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. | FV-RF | 12/11/1998 |
| K183541 | Prognosys Medical Systems Private Limited | ProRad 2FC and ProRad 3NC Stationary Radiographic Systems | 01/24/2019 |
| K151924 | QUANTUM MEDICAL IMAGING DIVISON OF CARESTREAM | Q-Rad Radiographic System with Auto-Tracker Option | 08/07/2015 |
| K011486 | QUANTUM MEDICAL IMAGING, LLC. | Q-RAD RADIOGRAPHIC SYSTEM | 06/20/2001 |
| K072010 | QUANTUM MEDICAL IMAGING, LLC. | QUANTUM DIREX SYSTEM | 08/07/2007 |
| K083181 | QUANTUM MEDICAL IMAGING, LLC. | QV-9000 UNIVERSAL SYSTEM | 11/26/2008 |
| K023008 | QUANTUM MEDICAL IMAGING, LLC. | UNIVERSAL SYSTEM, MODEL QV-800 | 11/13/2002 |
| K132294 | RADIOLOGY SOLUTIONS LLC | GALAXY AND GALAXY+PLUS DIGITAL RADIOGRAPHY SYSTEMS | 11/12/2013 |
| K193360 | Radmedix LLC | Acuity SDR Standard, Acuity SDR Plus, Acuity FDR Standard | 01/02/2020 |
| K972000 | RALPH LINDEL, D.C. | X-RAY ASSIST BAR | 07/08/1997 |
| K133496 | ROESYS GMBH | X TWIN SYSTEM | 12/03/2014 |
| K143029 | SAMSUNG ELECTRONICS CO., LTD. | Digital Diagnostic X-ray System (GC80) | 02/04/2015 |
| K123106 | SAMSUNG ELECTRONICS CO., LTD. | DIGITAL DIAGNOSTIC X-RAY SYSTEM MODEL XGEO GU60A | 06/20/2013 |
| K163115 | SAMSUNG ELECTRONICS CO., LTD. | GC70 | 12/07/2016 |
| K182647 | Samsung Electronics Co., Ltd. | GC70 | 10/24/2018 |
| K182183 | Samsung Electronics Co., LTD. | GC70, GU60A, GU60A-65, GF50, GR50A ; GR40CW ; GM85 ; GC85A | 12/07/2018 |
| K160997 | SAMSUNG ELECTRONICS CO., LTD. | GC85A | 07/06/2016 |
| K181629 | Samsung Electronics Co., Ltd. | GC85A | 07/20/2018 |
| K150165 | SAMSUNG ELECTRONICS CO., LTD. | GC85A | 04/02/2015 |
| K151419 | SAMSUNG ELECTRONICS CO., LTD. | GF50A | 06/23/2015 |
| K182622 | SAMSUNG ELECTRONICS CO., LTD. | GU60A, GU60A-65 | 10/23/2018 |
| K151685 | SAMSUNG ELECTRONICS CO., LTD. | GUA60A, GU60A-65 | 07/17/2015 |
| K140334 | SAMSUNG ELECTRONICS CO., LTD. | XGEO GC80 | 05/28/2014 |
| K123098 | SAMSUNG ELECTRONICS CO., LTD. | XGEO GC80 | 01/18/2013 |
| K140326 | SAMSUNG ELECTRONICS CO., LTD. | XGEO GF50 | 05/29/2014 |
| K123105 | SAMSUNG ELECTRONICS CO., LTD. | XGEO GU60 | 06/07/2013 |
| K140332 | SAMSUNG ELECTRONICS CO., LTD. | XGEO GU60A | 05/28/2014 |
| K180543 | Samsung Electronics Co.,Ltd. | GC70, GU60A&GU60A-65, GF50, GF50A, GR40CW, and GM85 | 05/24/2018 |
| K172229 | Samsung Electronics Co.,Ltd. | GC85A | 11/22/2017 |
| K173828 | Samsung Electronics Co.,Ltd. | GU60A & GU60A-65 | 01/12/2018 |
| K062335 | SEDECAL S.A. | SEDECAL X PLUS LP PLUS | 09/14/2006 |
| K090238 | SEDECAL S.A. | SEDECAL X-PLUS LP PLUS DIGITAL DIAGNOSTIC X-RAY SYSTEMS | 02/27/2009 |
| K090279 | SEDECAL S.A. | SEDECAL, MILLENNIUM PLUS | 03/11/2009 |
| K042876 | SEDECAL S.A. | URS LP DIGITAL, MILLENNIUM, RADPRO | 11/18/2004 |
| K203537 | SEDECAL SA | Proteus XR/f, Models ST and ET, Multirad and Multirad NET Radiographic Systems | 02/01/2021 |
| K012546 | SEDECAL USA, INC. | OPTIMA URS UNIVERSAL RADIOGRAPHIC SYSTEM | 11/02/2001 |
| K202293 | Sedecal, SA. | Radiographic System Challenge X | 10/07/2020 |
| K230241 | SG Healthcare CO LTD | Jumong General | 02/23/2023 |
| K150816 | SG HEALTHCARE CO LTD | Jumong Series | 05/08/2015 |
| K192293 | Shanghai United Imaging Healthcare Co., Ltd. | uDR 592h, uDR 596i | 09/12/2019 |
| K173953 | Shanghai United Imaging Healthcare Co., Ltd. | uDR 780i | 01/26/2018 |
| K181413 | Shanghai United Imaging Healthcare Co.,Ltd. | uDR 592h, uDR 596i | 06/27/2018 |
| K990715 | SHIMADZU CORP. | SHIMADZU CEILING TUBE SUPPORT CH-30GH | 04/16/1999 |
| K152294 | SHIMADZU CORPORATION | FDR Visionary Suite | 07/15/2016 |
| K173517 | SHIMADZU corporation | RADspeed fit | 03/30/2018 |
| K152244 | SHIMADZU CORPORATION | RADspeed Pro | 06/20/2016 |
| K121513 | SIEMENS MEDICAL SOLUTION | MULTIX FUSION | 08/10/2012 |
| K001201 | SIEMENS MEDICAL SOLUTIONS USA, INC. | MULTIX COMPACT K AND MULTIX L RADIOGRAPHIC X-RAY SYSTEMS | 06/01/2000 |
| K162971 | SIEMENS MEDICAL SOLUTIONS USA, INC. | Multix Fusion Max | 11/22/2016 |
| K191418 | Siemens Medical Solutions USA, Inc. | Multix Fusion Max | 06/19/2019 |
| K142049 | SIEMENS MEDICAL SOLUTIONS USA, INC. | MULTIX FUSION VA30 & VA40 | 12/18/2014 |
| K203345 | Siemens Medical Solutions USA, Inc. | MULTIX Impact | 01/07/2021 |
| K193089 | Siemens Medical Solutions USA, Inc. | MULTIX Impact | 03/20/2020 |
| K203340 | Siemens Medical Solutions USA, Inc. | MULTIX Impact C | 01/06/2021 |
| K220919 | Siemens Medical Solutions USA, Inc. | MULTIX Impact E | 05/17/2022 |
| K213700 | Siemens Medical Solutions USA, Inc. | MULTIX Impact, MULTIX Impact C | 12/13/2021 |
| K081722 | SIEMENS MEDICAL SOLUTIONS USA, INC. | YSIO | 08/22/2008 |
| K133259 | SIEMENS MEDICAL SOLUTIONS USA, INC. | YSIO MAX | 01/24/2014 |
| K201670 | Siemens Medical Solutions USA, Inc. | YSIO X.pree | 10/21/2020 |
| K182517 | Siemens Medical Solutions, Inc. | MULTIX Impact | 01/11/2019 |
| K132934 | SIEMENS MEDICAL SOLUTIONS, INC. | MULTIX SELECT DR | 04/10/2014 |
| K181279 | Siemens Medical Solutions, Inc. | Ysio Max | 06/13/2018 |
| K013826 | SIEMENS MEDICAL SYSTEMS, INC. | AXIOM ARISTOS FX (MULTI PURPOSE RADIOGRAPHY SYSTEM) | 02/01/2002 |
| K220518 | Skanray Technologies Limited | SKANRAD 400 | 04/01/2022 |
| K133959 | SOURCE-RAY, INC. | PODIATRY X-RAY SYSTEM | 01/22/2015 |
| K071392 | SOURCE-RAY, INC. | PXS-810, PODIATRY X-RAY SYSTEM | 08/03/2007 |
| K083109 | SUINSA | SUINSA DIAGNOSTIC X-RAY SYSTEM | 12/04/2008 |
| K173823 | Summit Industries LLC | Amrad Medical AAU Digital Radiography System; Amrad Medical AAU Plus Digital Radiography System; Amrad Medical DFMT Digital Radiography System; Amrad Medical FMT Digital Radiography System | 02/09/2018 |
| K153119 | SUMMIT INDUSTRIES LLC | Amrad Medical OTS Digital Radiography System, Amrad Medical DFMTS Digital Radiography SystemAmrad Medical FRS Digital Radiography System, | 03/14/2016 |
| K070678 | SWISSRAY INTERNATIONAL, INC. | DDRCOMPACT, DDRCOMPACT PLUS AND DDRCOMPACT CHEST | 05/02/2007 |
| K973710 | SWISSRAY INTERNATIONAL, INC. | DIGITAL ADD ON MULTI SYSTEM | 12/18/1997 |
| K110828 | SWISSRAY MEDICAL AG | DDRELEMENT | 08/23/2011 |
| K052943 | SWISSRAY MEDICAL AG | DDRFORMULA AND DDRFORMULA PLUS | 12/15/2005 |
| K970136 | SWISSRAY TELERAY AG | DIGITAL ADD-ON BUCKY | 11/21/1997 |
| K180765 | Televere Systems, Inc. | Televere Podiatry X-Ray System HF | 04/20/2018 |
| K083503 | TOSHIBA AMERICA MEDICAL SYSTEMS, INC. | DRAD30003/RADREX-I | 02/13/2009 |
| K981056 | VARIAN MEDICAL SYSTEMS, INC. | VARIAN XIMATRON SCAN VISION CT | 06/12/1998 |
| K092830 | VATECH CO., LTD. | DIGITAL X-RAY IMAGING SYSTEM, MODEL DRC-1000 | 07/21/2010 |
| K974112 | VICTOREEN, INC. | VACUDAP, MODEL 2000, 2001 | 01/29/1998 |
| K080553 | VIEWORKS CO., LTD. | DIGITAL RADIOGRAPHY SYSTEM, MODEL QXR-16 | 04/16/2008 |
| K150725 | VISARIS d.o.o. Belgrade | Visaris Avanse | 06/08/2015 |
| K160620 | VISARIS D.O.O. BELGRADE | Visaris Vision« (Vision C, Vision U. Vision V, Vision X) | 03/30/2016 |
| K102123 | VIZTEK, INC. | VIZION DR | 01/24/2011 |
| K082604 | VIZTEK, INC. | VIZTEK DR, MODELS: DR1000, DR3000, DR4000 | 11/21/2008 |
| K091752 | VIZTEK, INC. | VIZTEK WL | 11/12/2009 |
| K202388 | VMI Tecnologias LTDA | Apolo D / Apolo S | 12/01/2020 |
| K981880 | WUESTEC MEDICAL, INC. | DX-480, ADD ON DIGITAL IMAGER | 10/20/1998 |
| K993962 | WUESTEC MEDICAL, INC. | PENSIL TRAUMA, MODEL WWS6100 | 12/21/1999 |
| K220149 | XERA Medical Systems & Technology Ltd. | General Radiography X-ray System (Model: GR10X 40K), General Radiography X-ray System (Model: GR10X 50K) | 04/19/2022 |
| K201825 | Xoran Technologies LLC | MiniCAT 2D | 11/20/2020 |
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