| Nexus DRF Digital X-ray Imaging System (K253103) | Varex Imaging Corporation | 2026-05-29 |
| Insight Enhanced™ DRF (EN-1002-01) (K251650) | Imaging Engineering, LLC | 2025-09-16 |
| Soteria E-View (K242488) | Omega Medical Imaging, LLC | 2025-01-06 |
| Adora DRFi (04550010) (K242948) | Nrt X-Ray A/S | 2024-12-23 |
| TRIDENT Mobile Fluoroscopy System (K233380) | Dornier Medtech America | 2024-06-26 |
| ProxiDiagnost N90 / Precision CRF (706110, 706400) (K233945) | Philips Medical Systems Dmc GmbH | 2024-01-11 |
| CombiDiagnost R90 (K232910) | Philips Medical Systems Dmc GmbH | 2023-10-19 |
| XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5 (K232526) | Canon Medical Systems Corporation | 2023-09-12 |
| Nautilus (K220871) | Dornier Medtech America, Inc. | 2022-04-18 |
| Nyquist.IQ (K212890) | Omega Medical Imaging, LLC | 2021-12-13 |
| ProxiDiagnost N90 (K212837) | Philips Medical Systems Dmc GmbH | 2021-09-21 |
| DR 800 with DSA, DR 800 (K212145) | Agfa N.V. | 2021-08-31 |
| Insight Agile DRF (K210469) | Imaging Engineering, LLC | 2021-07-27 |
| Ziehm Vision RFD (K203428) | Ziehm Imaging GmbH | 2021-03-17 |
| Platinum dRF Imaging System (K203010) | Apelem-Dms Group | 2021-01-22 |
| XR-MX/1000 (K200965) | Karl Storz Endoscopy America, Inc. | 2020-12-29 |
| CombiDiagnost R90 (K203087) | Philips Medical Systems Dmc GmbH | 2020-12-03 |
| ArtPIX DRF (K202235) | Cmt Medical Technologies, Ltd. | 2020-09-03 |
| Insight Enhanced DRF Digital Imaging System (K200396) | Imaging Engineering, LLC | 2020-03-06 |
| CS-series-FP Radiographic / Fluoroscopic Systems with Optional CA-100S / FluoroShield™ (ROI Assembly) (K191713) | Omega Medical Imaging, LLC | 2019-10-04 |
| PowerDR (K191504) | Radiology Information Systems, Inc. | 2019-08-16 |
| FLUOROspeed (K191877) | Shimadzu Corporation | 2019-08-05 |
| Insight Essentials DRF Digital Imaging System (K191310) | Imaging Engineering, LLC | 2019-06-10 |
| CS-series-FP with Optional ROI Accessory CA-100S (K182834) | Omega Medical Imaging, LLC | 2019-03-29 |
| SonialVision G4 (K190373) | Shimadzu Corporation | 2019-03-15 |
| MECALL CLISIS SYSTEMS, Discovery RF180 (K173395) | General Medical Merate S.P.A | 2018-05-21 |
| Uroview FD II (K180651) | Pausch Medical GmbH | 2018-04-12 |
| DR 800 with MUSICA Dynamic (K180589) | Agfa Healthcare N.V. | 2018-04-05 |
| Philips CombiDiagnost R90 (K163210) | Philips Medical Systems Dmc GmbH | 2017-01-31 |
| Uroview FD (K161019) | Pausch Medical GmbH | 2016-08-17 |
| Platinum dRF Imaging System (K160301) | Apelem-Dms Group | 2016-03-04 |
| D2RS_AT Digital Dynamic Remote System (K150306) | Stephanix Radiological Solutions | 2015-10-10 |
| GENESIS (K151485) | Dornier Medtech America, Inc. | 2015-06-30 |
| X-RAY TV SYSTEM SONIALVISION G4 (K142341) | Shimadzu Corp. | 2015-03-06 |
| GENESIS II (K133434) | Dornier Medtech America, Inc. | 2014-11-26 |
| OPERA SWING (K140380) | General Medical Merate S.P.A | 2014-09-26 |
| XIDF-AWS801, ANGIO WORKSTATION, V5.31 (K141541) | Toshibamedical Systems Corporation | 2014-09-08 |
| GEMSS MEDICAL SYSTEMS SURGICAL MOBILE FLUOROSCOPIC X-RAY SYSTEM (K132289) | Gemss Medical Systems Co., Ltd. | 2014-06-16 |
| KALARE (K133553) | Toshiba America Medical Systems, In.C | 2014-06-13 |
| X-RAY TV SYSTEM SONIAL VISION G4 (K131075) | Shimadzu Corp. | 2014-03-28 |
| PLATINUM DRF IMAGING SYSTEM (K131766) | Apelem-Dms Group | 2013-12-12 |
| ZIEHM VISION RFD (K132904) | Ziehm Imaging GmbH | 2013-12-05 |
| INFINIX ANGIO WORKSTATION W/DTS SOFTWARE (K132106) | Toshiba America Medical Systems, In.C | 2013-11-12 |
| NEXUS DRF DIGITAL X-RAY IMAGING SYSTEM (WITH PAXSCAN 4343CB) (K130318) | Varian Medical Systems, X-Ray Products-Infimed | 2013-04-22 |
| DOSE TRACKING SYSTEM MODEL XIDF-DTS801 (K123097) | Toshiba America Medical Systems, In.C | 2013-02-13 |
| GENESIS (K122768) | Dornier Medtech America, Inc. | 2013-01-18 |
| CS-SERIES-FP WITH 3030+OPTION (K121293) | Omega Medical Imaging, LLC | 2012-07-26 |
| INFINIX CF-I/SP AND INFINIX VF-I/SP MODEL INFX-8000V (K112054) | Toshiba Medical Systems Corporation, Japan | 2011-08-05 |
| LUMINOS AGILE (K111292) | Siemens Medical Solutions USA, Inc. | 2011-06-03 |
| KALARE DIAGNOSTIC X-RAY TABLE SYSTEM (K110785) | Toshiba Medical Systems Coporation, Japan | 2011-05-27 |
| DUET DRF (K103038) | Cmt Medical Technologies, Ltd. | 2011-03-29 |
| UROSKOP OMNIA (K101491) | Siemens Medical Solutions USA, Inc. | 2010-06-30 |
| INFX-8000H, INFINIX-I (K082830) | Toshiba America Medical Systems, In.C | 2008-10-10 |
| INFX-8000C (INFINIX CC-I AND VC-I) (K081621) | Toshiba America Medical Systems, In.C | 2008-06-23 |
| SMITH & NEPHEW CDS SYSTEM (K081491) | Smith & Nephew, Inc. | 2008-06-19 |
| INFX-8000V, INFINIX-CFI AND INFINIX VFI (K081582) | Toshiba America Medical Systems, In.C | 2008-06-17 |
| PRECISION 500D R&F X-RAY SYSTEM (K081091) | GE Healthcare | 2008-06-11 |
| DRF 4343 (K080859) | Villa Sistemi Medicali S.P.A. | 2008-06-04 |
| FLUOROPRO RF DIGITAL IMAGING SYSTEM (K070390) | Virtual Imaging, Inc. | 2007-04-05 |
| PRECISION THUNIS 800+ (K061028) | Ge Medical Systems, LLC | 2006-06-07 |
| IMAGE STAR II (K052610) | Lakeshore Technologies, Inc. | 2005-11-30 |
| AXIOM SIRESKOP SD (K051602) | Siemens Medical Systems, Inc. | 2005-07-07 |
| SMITH & NEPHEW CDS SYSTEM (K051136) | Smith & Nephew, Inc. | 2005-07-01 |
| FLUOROSCAN INSIGHT MINI C-ARM FLUOROSCOPIC IMAGING SYSTEM (K051025) | Hologic, Inc. | 2005-05-13 |
| CENTRION 500 C-ARM SYSTEM (K050866) | Osteosys Co.,Ltd | 2005-04-27 |
| FLXIS (K050692) | Philips Medical Systems North America Co. | 2005-04-08 |
| UNFORS PATIENT SKIN DOSIMETER (PSD) (K042698) | Unfors, Inc. | 2004-10-22 |
| SHIMADZU IMAGE AMPLIFIER, MODEL IA-16L/HS (K040870) | Shimadzu Corp. | 2004-05-17 |
| OEC 9800 E/CV+ DIGITAL MOBILE IMAGING SYSTEM (K024012) | Ge Oec Medical Systems | 2003-03-20 |
| MODEL AMI1200 C-ARM (K022911) | Integrity Practice Management, Inc. | 2002-12-02 |
| PHILIPS INTEGRIS ALLURA FLAT DETECTOR RELEASE 1.0 (K022899) | Philips Medical Systems North America Co. | 2002-11-22 |
| TELSTAR BIPLANE DIGITAL IMAGING SYSTEM [TIS] MODEL 030-000915 (K022565) | Stereotaxis, Inc. | 2002-10-08 |
| MODULAR ANGIOGRAPHY SYSTEM AXIOM ARTIS (K021021) | Siemens Medical Solutions USA, Inc. | 2002-06-06 |
| PHILIPS INTEGRIS ALLURA 9 WITH FD OPTION (K020055) | Philips Medical Systems | 2002-03-15 |
| SHIMADZU IMAGE AMPLIFIER MODEL # IA-16LM (K012424) | Shimadzu Corp. | 2001-10-18 |
| ISI-2500 CCD C-ARM, ISI-2500 PLUS CCD C-ARM (K010772) | Imaging Services, Inc. | 2001-08-23 |
| EXPEDIO 500D R&F X-RAY SYSTEM (K011624) | GE Medical Systems | 2001-06-08 |
| ATHENA REMOTE CONTROLLED RF SYSTEM (K010392) | Cares Built, Inc. | 2001-03-12 |
| KIMAX, MODEL 1024 (K010187) | Medical Metrics, Inc. | 2001-02-14 |
| X-RAY SYSTEM XR-MX (K004037) | Karl Storz Endoscopy | 2001-02-02 |
| VFSS IMAGER, MODEL SIS-300 (K000987) | Lifecare Imaging Intl., Ltd. | 2000-06-01 |
| MCA-601, C-ARM MOBILE (K993896) | Medison Radiology Systems, Inc. | 2000-03-27 |
| XRT 600 R/F, WRF 0600 (K992603) | Wuestec Medical, Inc. | 1999-10-25 |
| TOSHIBA RTP9211J-G11, J-ADVANCED IMAGE INTENSIFIER (I.I.) (K993038) | Toshiba America Medical Systems, In.C | 1999-10-07 |
| B-400 CEILING MOUNTED POSSITIONER, MODEL B-400 (K990055) | Omega Medical Imaging, Inc. | 1999-02-02 |
| CAREGRAPH (K982319) | Siemens Medical Solutions USA, Inc. | 1998-09-22 |
| VASCO SCANNING BEAM DIGITAL X-RAY SYSTEM (K982345) | Cardiac Mariners, Inc. | 1998-09-01 |
| LC POSITIONER (K981414) | Fischer Imaging Corp. | 1998-07-16 |
| FLUOROSPOT COMPACT (K982028) | Siemens Medical Solutions USA, Inc. | 1998-07-14 |
| SYMPHONY 360 REMOTE CONTROL TABLE (K981227) | Acoma Medical Imaging, Inc. | 1998-06-30 |
| FS IV MINI C-ARM SYSTEM (K974058) | Hologic, Inc. | 1998-01-12 |
| UNICATH SP BI-PLANE (MODEL M269 & M289) (K973744) | Xre Corp. | 1997-12-29 |
| DRTS REMOTE CONTROL DRAPE (K973067) | Minrad, Inc. | 1997-10-16 |
| DRTS IMAGE INTENSIFIER DRAPE (K973073) | Minrad, Inc. | 1997-10-08 |
| CEILING MOUNTED LATERAL POSITIONER, MODEL NO. 6896.002 (K972442) | Continental X-Ray Corp. | 1997-09-11 |
| B-350 CEILING MOUNTED C-POSITIONER (K970947) | Omega Medical Imaging, Inc. | 1997-05-14 |
| EVT MARKER BOARD (K970608) | Guidant Cardiac and Vascular Surgery | 1997-04-21 |
| BIO-BINKI (K961782) | Biomni Medical Systems, Inc. | 1997-03-28 |
| HITACHI SX-VA30 C-ARM FLUOROSCOPIC/ANGIOGRAPHIC SYSTEM (SX-VA30) (K964990) | Hitachi Medical Systems America, Inc. | 1997-02-26 |
| VIPOR UNIT (K964322) | Tilane Corp. | 1997-02-26 |