JAA · Class II · 21 CFR 892.1650

FDA Product Code JAA: System, X-ray, Fluoroscopic, Image-intensified

Leading manufacturers include Toshiba America Medical Systems, In.C, General Electric Co. and Shimadzu Medical Systems.

300
Total
300
Cleared
89d
Avg days
1976
Since
300 devices
25–48 of 300
Cleared Mar 15, 2019
SonialVision G4
K190373
Shimadzu Corporation
Radiology · 24d
Cleared May 21, 2018
MECALL CLISIS SYSTEMS, Discovery RF180
K173395
General Medical Merate S.P.A
Radiology · 203d
Cleared Apr 12, 2018
Uroview FD II
K180651
Pausch Medical GmbH
Radiology · 30d
Cleared Apr 05, 2018
DR 800 with MUSICA Dynamic
K180589
Agfa Healthcare N.V.
Radiology · 30d
Cleared Jan 31, 2017
Philips CombiDiagnost R90
K163210
Philips Medical Systems Dmc GmbH
Radiology · 77d
Cleared Aug 17, 2016
Uroview FD
K161019
Pausch Medical GmbH
Radiology · 127d
Cleared Mar 04, 2016
Platinum dRF Imaging System
K160301
Apelem-Dms Group
Radiology · 29d
Cleared Oct 10, 2015
D2RS_AT Digital Dynamic Remote System
K150306
Stephanix Radiological Solutions
Radiology · 243d
Cleared Jun 30, 2015
GENESIS
K151485
Dornier Medtech America, Inc.
Radiology · 28d
Cleared Mar 06, 2015
X-RAY TV SYSTEM SONIALVISION G4
K142341
Shimadzu Corp.
Radiology · 197d
Cleared Nov 26, 2014
GENESIS II
K133434
Dornier Medtech America, Inc.
Radiology · 383d
Cleared Sep 26, 2014
OPERA SWING
K140380
General Medical Merate S.P.A
Radiology · 224d
Cleared Sep 08, 2014
XIDF-AWS801, ANGIO WORKSTATION, V5.31
K141541
Toshibamedical Systems Corporation
Radiology · 90d
Cleared Jun 16, 2014
GEMSS MEDICAL SYSTEMS SURGICAL MOBILE FLUOROSCOPIC X-RAY SYSTEM
K132289
Gemss Medical Systems Co., Ltd.
Radiology · 328d
Cleared Jun 13, 2014
KALARE
K133553
Toshiba America Medical Systems, In.C
Radiology · 206d
Cleared Mar 28, 2014
X-RAY TV SYSTEM SONIAL VISION G4
K131075
Shimadzu Corp.
Radiology · 345d
Cleared Dec 12, 2013
PLATINUM DRF IMAGING SYSTEM
K131766
Apelem-Dms Group
Radiology · 178d
Cleared Dec 05, 2013
ZIEHM VISION RFD
K132904
Ziehm Imaging GmbH
Radiology · 80d
Cleared Nov 12, 2013
INFINIX ANGIO WORKSTATION W/DTS SOFTWARE
K132106
Toshiba America Medical Systems, In.C
Radiology · 127d
Cleared Apr 22, 2013
NEXUS DRF DIGITAL X-RAY IMAGING SYSTEM (WITH PAXSCAN 4343CB)
K130318
Varian Medical Systems, X-Ray Products-Infimed
Radiology · 73d
Cleared Feb 13, 2013
DOSE TRACKING SYSTEM MODEL XIDF-DTS801
K123097
Toshiba America Medical Systems, In.C
Radiology · 134d
Cleared Jan 18, 2013
GENESIS
K122768
Dornier Medtech America, Inc.
Radiology · 130d
Cleared Jul 26, 2012
CS-SERIES-FP WITH 3030+OPTION
K121293
Omega Medical Imaging, LLC
Radiology · 87d
Cleared Aug 05, 2011
INFINIX CF-I/SP AND INFINIX VF-I/SP MODEL INFX-8000V
K112054
Toshiba Medical Systems Corporation, Japan
Radiology · 17d