Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
JAA — Predicate Candidate Screening
300 FDA 510(k) clearances under this product code; the 50 most recent screened below.
67 daysmedian FDA review time
171 days90th percentile
300clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253103 | Nexus DRF Digital X-ray Imaging System | Varex Imaging Corporation | 2026-05-29 | 247 | 0 |
| K251650 | Insight Enhancedâ„¢ DRF (EN-1002-01) | Imaging Engineering, LLC | 2025-09-16 | 110 | 0 |
| K242488 | Soteria E-View | Omega Medical Imaging, LLC | 2025-01-06 | 138 | 0 |
| K242948 | Adora DRFi (04550010) | Nrt X-Ray A/S | 2024-12-23 | 89 | 0 |
| K233380 | TRIDENT Mobile Fluoroscopy System | Dornier Medtech America | 2024-06-26 | 268 | 0 |
| K233945 | ProxiDiagnost N90 / Precision CRF (706110, 706400) | Philips Medical Systems Dmc GmbH | 2024-01-11 | 28 | 2 |
| K232910 | CombiDiagnost R90 | Philips Medical Systems Dmc GmbH | 2023-10-19 | 30 | 1 |
| K232526 | XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5 | Canon Medical Systems Corporation | 2023-09-12 | 22 | 0 |
| K220871 | Nautilus | Dornier Medtech America, Inc. | 2022-04-18 | 24 | 0 |
| K212890 | Nyquist.IQ | Omega Medical Imaging, LLC | 2021-12-13 | 94 | 0 |
| K212837 | ProxiDiagnost N90 | Philips Medical Systems Dmc GmbH | 2021-09-21 | 14 | 5 |
| K212145 | DR 800 with DSA, DR 800 | Agfa N.V. | 2021-08-31 | 53 | 0 |
| K210469 | Insight Agile DRF | Imaging Engineering, LLC | 2021-07-27 | 161 | 0 |
| K203428 | Ziehm Vision RFD | Ziehm Imaging GmbH | 2021-03-17 | 117 | 0 |
| K203010 | Platinum dRF Imaging System | Apelem-Dms Group | 2021-01-22 | 113 | 0 |
| K200965 | XR-MX/1000 | Karl Storz Endoscopy America, Inc. | 2020-12-29 | 263 | 0 |
| K203087 | CombiDiagnost R90 | Philips Medical Systems Dmc GmbH | 2020-12-03 | 51 | 4 |
| K202235 | ArtPIX DRF | Cmt Medical Technologies, Ltd. | 2020-09-03 | 27 | 0 |
| K200396 | Insight Enhanced DRF Digital Imaging System | Imaging Engineering, LLC | 2020-03-06 | 17 | 0 |
| K191713 | CS-series-FP Radiographic / Fluoroscopic Systems with Option | Omega Medical Imaging, LLC | 2019-10-04 | 100 | 0 |
| K191504 | PowerDR | Radiology Information Systems, Inc. | 2019-08-16 | 71 | 0 |
| K191877 | FLUOROspeed | Shimadzu Corporation | 2019-08-05 | 21 | 1 |
| K191310 | Insight Essentials DRF Digital Imaging System | Imaging Engineering, LLC | 2019-06-10 | 26 | 0 |
| K182834 | CS-series-FP with Optional ROI Accessory CA-100S | Omega Medical Imaging, LLC | 2019-03-29 | 171 | 0 |
| K190373 | SonialVision G4 | Shimadzu Corporation | 2019-03-15 | 24 | 1 |
| K173395 | MECALL CLISIS SYSTEMS, Discovery RF180 | General Medical Merate S.P.A | 2018-05-21 | 203 | 0 |
| K180651 | Uroview FD II | Pausch Medical GmbH | 2018-04-12 | 30 | 0 |
| K180589 | DR 800 with MUSICA Dynamic | Agfa Healthcare N.V. | 2018-04-05 | 30 | 1 |
| K163210 | Philips CombiDiagnost R90 | Philips Medical Systems Dmc GmbH | 2017-01-31 | 77 | 6 |
| K161019 | Uroview FD | Pausch Medical GmbH | 2016-08-17 | 127 | 0 |
| K160301 | Platinum dRF Imaging System | Apelem-Dms Group | 2016-03-04 | 29 | 0 |
| K150306 | D2RS_AT Digital Dynamic Remote System | Stephanix Radiological Solutions | 2015-10-10 | 243 | 0 |
| K151485 | GENESIS | Dornier Medtech America, Inc. | 2015-06-30 | 28 | 0 |
| K142341 | X-RAY TV SYSTEM SONIALVISION G4 | Shimadzu Corp. | 2015-03-06 | 197 | 0 |
| K133434 | GENESIS II | Dornier Medtech America, Inc. | 2014-11-26 | 383 | 0 |
| K140380 | OPERA SWING | General Medical Merate S.P.A | 2014-09-26 | 224 | 0 |
| K141541 | XIDF-AWS801, ANGIO WORKSTATION, V5.31 | Toshibamedical Systems Corporation | 2014-09-08 | 90 | 0 |
| K132289 | GEMSS MEDICAL SYSTEMS SURGICAL MOBILE FLUOROSCOPIC X-RAY SYS | Gemss Medical Systems Co., Ltd. | 2014-06-16 | 328 | 0 |
| K133553 | KALARE | Toshiba America Medical Systems, In.C | 2014-06-13 | 206 | 1 |
| K131075 | X-RAY TV SYSTEM SONIAL VISION G4 | Shimadzu Corp. | 2014-03-28 | 345 | 0 |
| K131766 | PLATINUM DRF IMAGING SYSTEM | Apelem-Dms Group | 2013-12-12 | 178 | 0 |
| K132904 | ZIEHM VISION RFD | Ziehm Imaging GmbH | 2013-12-05 | 80 | 0 |
| K132106 | INFINIX ANGIO WORKSTATION W/DTS SOFTWARE | Toshiba America Medical Systems, In.C | 2013-11-12 | 127 | 0 |
| K130318 | NEXUS DRF DIGITAL X-RAY IMAGING SYSTEM (WITH PAXSCAN 4343CB) | Varian Medical Systems, X-Ray Products-Infimed | 2013-04-22 | 73 | 0 |
| K123097 | DOSE TRACKING SYSTEM MODEL XIDF-DTS801 | Toshiba America Medical Systems, In.C | 2013-02-13 | 134 | 0 |
| K122768 | GENESIS | Dornier Medtech America, Inc. | 2013-01-18 | 130 | 0 |
| K121293 | CS-SERIES-FP WITH 3030+OPTION | Omega Medical Imaging, LLC | 2012-07-26 | 87 | 0 |
| K112054 | INFINIX CF-I/SP AND INFINIX VF-I/SP MODEL INFX-8000V | Toshiba Medical Systems Corporation, Japan | 2011-08-05 | 17 | 0 |
| K111292 | LUMINOS AGILE | Siemens Medical Solutions USA, Inc. | 2011-06-03 | 28 | 6 |
| K110785 | KALARE DIAGNOSTIC X-RAY TABLE SYSTEM | Toshiba Medical Systems Coporation, Japan | 2011-05-27 | 67 | 1 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda