ClearanceBrief
Panels › Radiology › Product code JAA · Class 2

System, X-Ray, Fluoroscopic, Image-Intensified

Regulation 892.1650

1510(k)s in 12 months (300 all time)
4recalls in 12 months (223 all time)
197recalls that name a 510(k)
Get daily alerts for JAASample briefCSV

Top companies in JAA

Company510(k)sRecalls
Ge Oec Medical Systems140
Siemens Medical Solutions USA, Inc.1029
GE Healthcare133
Philips North America023
Philips Medical Systems North America Co. Phillips022
Shimadzu Medical Systems105
Fischer Imaging Corp.104
Philips Medical Systems Dmc GmbH59
Toshiba America Medical Systems, In.C130
General Electric Co.100
Decided510(k)Device and applicantCode
May 29, 2026K253103Nexus DRF Digital X-ray Imaging System
Varex Imaging Corporation
JAA
Sep 16, 2025K251650Insight Enhanced™ DRF (EN-1002-01)
Imaging Engineering, LLC
JAA
Jan 6, 2025K242488Soteria E-View
Omega Medical Imaging, LLC
JAA
Dec 23, 2024K242948Adora DRFi (04550010)
Nrt X-Ray A/S, DK
JAA
Jun 26, 2024K233380TRIDENT Mobile Fluoroscopy System
Dornier Medtech America
JAA
Jan 11, 2024K233945ProxiDiagnost N90 / Precision CRF (706110, 706400)
Philips Medical Systems Dmc GmbH, DE
JAA
Oct 19, 2023K232910CombiDiagnost R90
Philips Medical Systems Dmc GmbH, DE
JAA
Sep 12, 2023K232526XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5
Canon Medical Systems Corporation, JP
JAA
Apr 18, 2022K220871Nautilus
Dornier Medtech America, Inc.
JAA
Dec 13, 2021K212890Nyquist.IQ
Omega Medical Imaging, LLC
JAA
Sep 21, 2021K212837ProxiDiagnost N90
Philips Medical Systems Dmc GmbH, DE
JAA
Aug 31, 2021K212145DR 800 with DSA, DR 800
Agfa N.V., BE
JAA
Jul 27, 2021K210469Insight Agile DRF
Imaging Engineering, LLC
JAA
Mar 17, 2021K203428Ziehm Vision RFD
Ziehm Imaging GmbH, DE
JAA
Jan 22, 2021K203010Platinum dRF Imaging System
Apelem-Dms Group, FR
JAA
Dec 29, 2020K200965XR-MX/1000
Karl Storz Endoscopy America, Inc.
JAA
Dec 3, 2020K203087CombiDiagnost R90
Philips Medical Systems Dmc GmbH, DE
JAA
Sep 3, 2020K202235ArtPIX DRF
Cmt Medical Technologies, Ltd., IL
JAA
Mar 6, 2020K200396Insight Enhanced DRF Digital Imaging System
Imaging Engineering, LLC
JAA
Oct 4, 2019K191713CS-series-FP Radiographic / Fluoroscopic Systems with Optional CA-100S / FluoroShield™ (ROI Assembly)
Omega Medical Imaging, LLC
JAA
Aug 16, 2019K191504PowerDR
Radiology Information Systems, Inc.
JAA
Aug 5, 2019K191877FLUOROspeed
Shimadzu Corporation, JP
JAA
Jun 10, 2019K191310Insight Essentials DRF Digital Imaging System
Imaging Engineering, LLC
JAA
Mar 29, 2019K182834CS-series-FP with Optional ROI Accessory CA-100S
Omega Medical Imaging, LLC
JAA
Mar 15, 2019K190373SonialVision G4
Shimadzu Corporation, JP
JAA
May 21, 2018K173395MECALL CLISIS SYSTEMS, Discovery RF180
General Medical Merate S.P.A, IT
JAA
Apr 12, 2018K180651Uroview FD II
Pausch Medical GmbH, DE
JAA
Apr 5, 2018K180589DR 800 with MUSICA Dynamic
Agfa Healthcare N.V., BE
JAA
Jan 31, 2017K163210Philips CombiDiagnost R90
Philips Medical Systems Dmc GmbH, DE
JAA
Aug 17, 2016K161019Uroview FD
Pausch Medical GmbH, DE
JAA
Mar 4, 2016K160301Platinum dRF Imaging System
Apelem-Dms Group, FR
JAA
Oct 10, 2015K150306D2RS_AT Digital Dynamic Remote System
Stephanix Radiological Solutions, FR
JAA
Jun 30, 2015K151485GENESIS
Dornier Medtech America, Inc.
JAA
Mar 6, 2015K142341X-RAY TV SYSTEM SONIALVISION G4
Shimadzu Corp., JP
JAA
Nov 26, 2014K133434GENESIS II
Dornier Medtech America, Inc.
JAA
Sep 26, 2014K140380OPERA SWING
General Medical Merate S.P.A
JAA
Sep 8, 2014K141541XIDF-AWS801, ANGIO WORKSTATION, V5.31
Toshibamedical Systems Corporation
JAA
Jun 16, 2014K132289GEMSS MEDICAL SYSTEMS SURGICAL MOBILE FLUOROSCOPIC X-RAY SYSTEM
Gemss Medical Systems Co., Ltd.
JAA
Jun 13, 2014K133553KALARE
Toshiba America Medical Systems, In.C
JAA
Mar 28, 2014K131075X-RAY TV SYSTEM SONIAL VISION G4
Shimadzu Corp.
JAA
Dec 12, 2013K131766PLATINUM DRF IMAGING SYSTEM
Apelem-Dms Group
JAA
Dec 5, 2013K132904ZIEHM VISION RFD
Ziehm Imaging GmbH
JAA
Nov 12, 2013K132106INFINIX ANGIO WORKSTATION W/DTS SOFTWARE
Toshiba America Medical Systems, In.C
JAA
Apr 22, 2013K130318NEXUS DRF DIGITAL X-RAY IMAGING SYSTEM (WITH PAXSCAN 4343CB)
Varian Medical Systems, X-Ray Products-Infimed
JAA
Feb 13, 2013K123097DOSE TRACKING SYSTEM MODEL XIDF-DTS801
Toshiba America Medical Systems, In.C
JAA
Jan 18, 2013K122768GENESIS
Dornier Medtech America, Inc.
JAA
Jul 26, 2012K121293CS-SERIES-FP WITH 3030+OPTION
Omega Medical Imaging, LLC
JAA
Aug 5, 2011K112054INFINIX CF-I/SP AND INFINIX VF-I/SP MODEL INFX-8000V
Toshiba Medical Systems Corporation, Japan
JAA
Jun 3, 2011K111292LUMINOS AGILE
Siemens Medical Solutions USA, Inc.
JAA
May 27, 2011K110785KALARE DIAGNOSTIC X-RAY TABLE SYSTEM
Toshiba Medical Systems Coporation, Japan
JAA

Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.