FDA Product Code
FDA Product Code JAA — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Radiology
- 21 CFR Citation
- 892.1650
510(k) Clearances — 300 records · page 1 of 3
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K253103 | Nexus DRF Digital X-ray Imaging System | Varex Imaging Corporation | 2026-05-29 | Traditional | PDF ↗ |
| K251650 | Insight Enhanced DRF (EN-1002-01) | Imaging Engineering, LLC | 2025-09-16 | Traditional | PDF ↗ |
| K242488 | Soteria E-View | Omega Medical Imaging, LLC | 2025-01-06 | Traditional | PDF ↗ |
| K242948 | Adora DRFi (04550010) | Nrt X-Ray A/S | 2024-12-23 | Traditional | PDF ↗ |
| K233380 | TRIDENT Mobile Fluoroscopy System | Dornier Medtech America | 2024-06-26 | Traditional | PDF ↗ |
| K233945 | ProxiDiagnost N90 / Precision CRF (706110, 706400) | Philips Medical Systems Dmc GmbH | 2024-01-11 | Special | PDF ↗ |
| K232910 | CombiDiagnost R90 | Philips Medical Systems Dmc GmbH | 2023-10-19 | Special | PDF ↗ |
| K232526 | XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5 | Canon Medical Systems Corporation | 2023-09-12 | Special | PDF ↗ |
| K220871 | Nautilus | Dornier Medtech America, Inc. | 2022-04-18 | Special | PDF ↗ |
| K212890 | Nyquist.IQ | Omega Medical Imaging, LLC | 2021-12-13 | Traditional | PDF ↗ |
| K212837 | ProxiDiagnost N90 | Philips Medical Systems Dmc GmbH | 2021-09-21 | Special | PDF ↗ |
| K212145 | DR 800 with DSA, DR 800 | Agfa N.V. | 2021-08-31 | Traditional | PDF ↗ |
| K210469 | Insight Agile DRF | Imaging Engineering, LLC | 2021-07-27 | Traditional | PDF ↗ |
| K203428 | Ziehm Vision RFD | Ziehm Imaging GmbH | 2021-03-17 | Special | PDF ↗ |
| K203010 | Platinum dRF Imaging System | Apelem-Dms Group | 2021-01-22 | Special | PDF ↗ |
| K200965 | XR-MX/1000 | Karl Storz Endoscopy America, Inc. | 2020-12-29 | Traditional | PDF ↗ |
| K203087 | CombiDiagnost R90 | Philips Medical Systems Dmc GmbH | 2020-12-03 | Traditional | PDF ↗ |
| K202235 | ArtPIX DRF | Cmt Medical Technologies, Ltd. | 2020-09-03 | Special | PDF ↗ |
| K200396 | Insight Enhanced DRF Digital Imaging System | Imaging Engineering, LLC | 2020-03-06 | Special | PDF ↗ |
| K191713 | CS-series-FP Radiographic / Fluoroscopic Systems with Optional CA-100S / FluoroShield (ROI Assembly) | Omega Medical Imaging, LLC | 2019-10-04 | Traditional | PDF ↗ |
| K191504 | PowerDR | Radiology Information Systems, Inc. | 2019-08-16 | Traditional | PDF ↗ |
| K191877 | FLUOROspeed | Shimadzu Corporation | 2019-08-05 | Special | PDF ↗ |
| K191310 | Insight Essentials DRF Digital Imaging System | Imaging Engineering, LLC | 2019-06-10 | Traditional | PDF ↗ |
| K182834 | CS-series-FP with Optional ROI Accessory CA-100S | Omega Medical Imaging, LLC | 2019-03-29 | Traditional | PDF ↗ |
| K190373 | SonialVision G4 | Shimadzu Corporation | 2019-03-15 | Special | PDF ↗ |
| K173395 | MECALL CLISIS SYSTEMS, Discovery RF180 | General Medical Merate S.P.A | 2018-05-21 | Special | PDF ↗ |
| K180651 | Uroview FD II | Pausch Medical GmbH | 2018-04-12 | Traditional | PDF ↗ |
| K180589 | DR 800 with MUSICA Dynamic | Agfa Healthcare N.V. | 2018-04-05 | Traditional | PDF ↗ |
| K163210 | Philips CombiDiagnost R90 | Philips Medical Systems Dmc GmbH | 2017-01-31 | Traditional | PDF ↗ |
| K161019 | Uroview FD | Pausch Medical GmbH | 2016-08-17 | Traditional | PDF ↗ |
| K160301 | Platinum dRF Imaging System | Apelem-Dms Group | 2016-03-04 | Special | PDF ↗ |
| K150306 | D2RS_AT Digital Dynamic Remote System | Stephanix Radiological Solutions | 2015-10-10 | Traditional | PDF ↗ |
| K151485 | GENESIS | Dornier Medtech America, Inc. | 2015-06-30 | Special | PDF ↗ |
| K142341 | X-RAY TV SYSTEM SONIALVISION G4 | Shimadzu Corp. | 2015-03-06 | Abbreviated | PDF ↗ |
| K133434 | GENESIS II | Dornier Medtech America, Inc. | 2014-11-26 | Traditional | PDF ↗ |
| K140380 | OPERA SWING | General Medical Merate S.P.A | 2014-09-26 | Traditional | PDF ↗ |
| K141541 | XIDF-AWS801, ANGIO WORKSTATION, V5.31 | Toshibamedical Systems Corporation | 2014-09-08 | Traditional | PDF ↗ |
| K132289 | GEMSS MEDICAL SYSTEMS SURGICAL MOBILE FLUOROSCOPIC X-RAY SYSTEM | Gemss Medical Systems Co., Ltd. | 2014-06-16 | Traditional | PDF ↗ |
| K133553 | KALARE | Toshiba America Medical Systems, In.C | 2014-06-13 | Traditional | PDF ↗ |
| K131075 | X-RAY TV SYSTEM SONIAL VISION G4 | Shimadzu Corp. | 2014-03-28 | Abbreviated | PDF ↗ |
| K131766 | PLATINUM DRF IMAGING SYSTEM | Apelem-Dms Group | 2013-12-12 | Traditional | PDF ↗ |
| K132904 | ZIEHM VISION RFD | Ziehm Imaging GmbH | 2013-12-05 | Special | PDF ↗ |
| K132106 | INFINIX ANGIO WORKSTATION W/DTS SOFTWARE | Toshiba America Medical Systems, In.C | 2013-11-12 | Traditional | PDF ↗ |
| K130318 | NEXUS DRF DIGITAL X-RAY IMAGING SYSTEM (WITH PAXSCAN 4343CB) | Varian Medical Systems, X-Ray Products-Infimed | 2013-04-22 | Special | PDF ↗ |
| K123097 | DOSE TRACKING SYSTEM MODEL XIDF-DTS801 | Toshiba America Medical Systems, In.C | 2013-02-13 | Traditional | PDF ↗ |
| K122768 | GENESIS | Dornier Medtech America, Inc. | 2013-01-18 | Traditional | PDF ↗ |
| K121293 | CS-SERIES-FP WITH 3030+OPTION | Omega Medical Imaging, LLC | 2012-07-26 | Traditional | PDF ↗ |
| K112054 | INFINIX CF-I/SP AND INFINIX VF-I/SP MODEL INFX-8000V | Toshiba Medical Systems Corporation, Japan | 2011-08-05 | Special | PDF ↗ |
| K111292 | LUMINOS AGILE | Siemens Medical Solutions USA, Inc. | 2011-06-03 | Special | PDF ↗ |
| K110785 | KALARE DIAGNOSTIC X-RAY TABLE SYSTEM | Toshiba Medical Systems Coporation, Japan | 2011-05-27 | Traditional | PDF ↗ |
| K103038 | DUET DRF | Cmt Medical Technologies, Ltd. | 2011-03-29 | Abbreviated | PDF ↗ |
| K101491 | UROSKOP OMNIA | Siemens Medical Solutions USA, Inc. | 2010-06-30 | Special | PDF ↗ |
| K082830 | INFX-8000H, INFINIX-I | Toshiba America Medical Systems, In.C | 2008-10-10 | Traditional | PDF ↗ |
| K081621 | INFX-8000C (INFINIX CC-I AND VC-I) | Toshiba America Medical Systems, In.C | 2008-06-23 | Traditional | PDF ↗ |
| K081491 | SMITH & NEPHEW CDS SYSTEM | Smith & Nephew, Inc. | 2008-06-19 | Special | PDF ↗ |
| K081582 | INFX-8000V, INFINIX-CFI AND INFINIX VFI | Toshiba America Medical Systems, In.C | 2008-06-17 | Traditional | PDF ↗ |
| K081091 | PRECISION 500D R&F X-RAY SYSTEM | GE Healthcare | 2008-06-11 | Traditional | PDF ↗ |
| K080859 | DRF 4343 | Villa Sistemi Medicali S.P.A. | 2008-06-04 | Traditional | PDF ↗ |
| K070390 | FLUOROPRO RF DIGITAL IMAGING SYSTEM | Virtual Imaging, Inc. | 2007-04-05 | Traditional | PDF ↗ |
| K061028 | PRECISION THUNIS 800+ | Ge Medical Systems, LLC | 2006-06-07 | Abbreviated | PDF ↗ |
| K052610 | IMAGE STAR II | Lakeshore Technologies, Inc. | 2005-11-30 | Traditional | PDF ↗ |
| K051602 | AXIOM SIRESKOP SD | Siemens Medical Systems, Inc. | 2005-07-07 | Traditional | PDF ↗ |
| K051136 | SMITH & NEPHEW CDS SYSTEM | Smith & Nephew, Inc. | 2005-07-01 | Traditional | PDF ↗ |
| K051025 | FLUOROSCAN INSIGHT MINI C-ARM FLUOROSCOPIC IMAGING SYSTEM | Hologic, Inc. | 2005-05-13 | Special | PDF ↗ |
| K050866 | CENTRION 500 C-ARM SYSTEM | Osteosys Co.,Ltd | 2005-04-27 | Traditional | PDF ↗ |
| K050692 | FLXIS | Philips Medical Systems North America Co. | 2005-04-08 | Traditional | PDF ↗ |
| K042698 | UNFORS PATIENT SKIN DOSIMETER (PSD) | Unfors, Inc. | 2004-10-22 | Traditional | PDF ↗ |
| K040870 | SHIMADZU IMAGE AMPLIFIER, MODEL IA-16L/HS | Shimadzu Corp. | 2004-05-17 | Traditional | PDF ↗ |
| K024012 | OEC 9800 E/CV+ DIGITAL MOBILE IMAGING SYSTEM | Ge Oec Medical Systems | 2003-03-20 | Traditional | PDF ↗ |
| K022911 | MODEL AMI1200 C-ARM | Integrity Practice Management, Inc. | 2002-12-02 | Traditional | PDF ↗ |
| K022899 | PHILIPS INTEGRIS ALLURA FLAT DETECTOR RELEASE 1.0 | Philips Medical Systems North America Co. | 2002-11-22 | Traditional | PDF ↗ |
| K022565 | TELSTAR BIPLANE DIGITAL IMAGING SYSTEM [TIS] MODEL 030-000915 | Stereotaxis, Inc. | 2002-10-08 | Special | PDF ↗ |
| K021021 | MODULAR ANGIOGRAPHY SYSTEM AXIOM ARTIS | Siemens Medical Solutions USA, Inc. | 2002-06-06 | Traditional | PDF ↗ |
| K020055 | PHILIPS INTEGRIS ALLURA 9 WITH FD OPTION | Philips Medical Systems | 2002-03-15 | Traditional | PDF ↗ |
| K012424 | SHIMADZU IMAGE AMPLIFIER MODEL # IA-16LM | Shimadzu Corp. | 2001-10-18 | Traditional | PDF ↗ |
| K010772 | ISI-2500 CCD C-ARM, ISI-2500 PLUS CCD C-ARM | Imaging Services, Inc. | 2001-08-23 | Traditional | PDF ↗ |
| K011624 | EXPEDIO 500D R&F X-RAY SYSTEM | GE Medical Systems | 2001-06-08 | Traditional | PDF ↗ |
| K010392 | ATHENA REMOTE CONTROLLED RF SYSTEM | Cares Built, Inc. | 2001-03-12 | Traditional | PDF ↗ |
| K010187 | KIMAX, MODEL 1024 | Medical Metrics, Inc. | 2001-02-14 | Abbreviated | PDF ↗ |
| K004037 | X-RAY SYSTEM XR-MX | Karl Storz Endoscopy | 2001-02-02 | Traditional | PDF ↗ |
| K000987 | VFSS IMAGER, MODEL SIS-300 | Lifecare Imaging Intl., Ltd. | 2000-06-01 | Traditional | PDF ↗ |
| K993896 | MCA-601, C-ARM MOBILE | Medison Radiology Systems, Inc. | 2000-03-27 | Traditional | PDF ↗ |
| K992603 | XRT 600 R/F, WRF 0600 | Wuestec Medical, Inc. | 1999-10-25 | Traditional | PDF ↗ |
| K993038 | TOSHIBA RTP9211J-G11, J-ADVANCED IMAGE INTENSIFIER (I.I.) | Toshiba America Medical Systems, In.C | 1999-10-07 | Traditional | PDF ↗ |
| K990055 | B-400 CEILING MOUNTED POSSITIONER, MODEL B-400 | Omega Medical Imaging, Inc. | 1999-02-02 | Traditional | PDF ↗ |
| K982319 | CAREGRAPH | Siemens Medical Solutions USA, Inc. | 1998-09-22 | Traditional | PDF ↗ |
| K982345 | VASCO SCANNING BEAM DIGITAL X-RAY SYSTEM | Cardiac Mariners, Inc. | 1998-09-01 | Traditional | PDF ↗ |
| K981414 | LC POSITIONER | Fischer Imaging Corp. | 1998-07-16 | Traditional | PDF ↗ |
| K982028 | FLUOROSPOT COMPACT | Siemens Medical Solutions USA, Inc. | 1998-07-14 | Traditional | PDF ↗ |
| K981227 | SYMPHONY 360 REMOTE CONTROL TABLE | Acoma Medical Imaging, Inc. | 1998-06-30 | Traditional | PDF ↗ |
| K974058 | FS IV MINI C-ARM SYSTEM | Hologic, Inc. | 1998-01-12 | Traditional | PDF ↗ |
| K973744 | UNICATH SP BI-PLANE (MODEL M269 & M289) | Xre Corp. | 1997-12-29 | Traditional | PDF ↗ |
| K973067 | DRTS REMOTE CONTROL DRAPE | Minrad, Inc. | 1997-10-16 | Traditional | PDF ↗ |
| K973073 | DRTS IMAGE INTENSIFIER DRAPE | Minrad, Inc. | 1997-10-08 | Traditional | PDF ↗ |
| K972442 | CEILING MOUNTED LATERAL POSITIONER, MODEL NO. 6896.002 | Continental X-Ray Corp. | 1997-09-11 | Traditional | PDF ↗ |
| K970947 | B-350 CEILING MOUNTED C-POSITIONER | Omega Medical Imaging, Inc. | 1997-05-14 | Traditional | PDF ↗ |
| K970608 | EVT MARKER BOARD | Guidant Cardiac and Vascular Surgery | 1997-04-21 | Traditional | PDF ↗ |
| K961782 | BIO-BINKI | Biomni Medical Systems, Inc. | 1997-03-28 | Traditional | PDF ↗ |
| K964990 | HITACHI SX-VA30 C-ARM FLUOROSCOPIC/ANGIOGRAPHIC SYSTEM (SX-VA30) | Hitachi Medical Systems America, Inc. | 1997-02-26 | Traditional | PDF ↗ |
| K964322 | VIPOR UNIT | Tilane Corp. | 1997-02-26 | Traditional | PDF ↗ |
Product code JAA · Class II · Radiology. Data: openFDA.