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, Siemens Medical Solutions USA, Inc. and Fischer Imaging Corp..

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 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 08, 2014
XIDF-AWS801, ANGIO WORKSTATION, V5.31
K141541
Toshibamedical Systems Corporation
Radiology · 90d
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 Nov 12, 2013
INFINIX ANGIO WORKSTATION W/DTS SOFTWARE
K132106
Toshiba America Medical Systems, In.C
Radiology · 127d
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 Jun 03, 2011
LUMINOS AGILE
K111292
Siemens Medical Solutions USA, Inc.
Radiology · 28d
Cleared Jun 30, 2010
UROSKOP OMNIA
K101491
Siemens Medical Solutions USA, Inc.
Radiology · 29d
Cleared Oct 10, 2008
INFX-8000H, INFINIX-I
K082830
Toshiba America Medical Systems, In.C
Radiology · 14d
Cleared Jun 23, 2008
INFX-8000C (INFINIX CC-I AND VC-I)
K081621
Toshiba America Medical Systems, In.C
Radiology · 14d
Cleared Jun 19, 2008
SMITH & NEPHEW CDS SYSTEM
K081491
Smith & Nephew, Inc.
Radiology · 22d
Cleared Jun 17, 2008
INFX-8000V, INFINIX-CFI AND INFINIX VFI
K081582
Toshiba America Medical Systems, In.C
Radiology · 12d
Cleared Jun 11, 2008
PRECISION 500D R&F X-RAY SYSTEM
K081091
Ge Healthcare
Radiology · 56d
Cleared Jun 07, 2006
PRECISION THUNIS 800+
K061028
Ge Medical Systems, LLC
Radiology · 55d
Cleared Jul 01, 2005
SMITH & NEPHEW CDS SYSTEM
K051136
Smith & Nephew, Inc.
Radiology · 58d
Cleared May 13, 2005
FLUOROSCAN INSIGHT MINI C-ARM FLUOROSCOPIC IMAGING SYSTEM
K051025
Hologic, Inc.
Radiology · 21d
Cleared May 17, 2004
SHIMADZU IMAGE AMPLIFIER, MODEL IA-16L/HS
K040870
Shimadzu Corp.
Radiology · 45d