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
121–144 of 300
Cleared May 15, 1995
SIRESKOP SX
K951358
Siemens Medical Solutions USA, Inc.
Radiology · 52d
Cleared May 11, 1995
SHIMADZU IMAGE AMPLIFIER IA-12LM SERIES
K936236
Shimadzu Medical Systems
Radiology · 497d
Cleared May 06, 1995
ARTHROGRAM TRAY
K950683
Surgical Technologies, Inc.
Radiology · 81d
Cleared May 04, 1995
SYSTEM, IMAGE PROCESSING
K943156
Image Technology, Inc.
Radiology · 308d
Cleared Apr 11, 1995
MOBIL C-ARM, REGURBISHED, VARIOUS MODELS
K950971
Pro-Tronics, Inc.
Radiology · 49d
Cleared Mar 24, 1995
ID400 SERIES ARMBOARDS
K950631
Image Diagnostics, Inc.
Radiology · 39d
Cleared Mar 14, 1995
PHILIPS CD MEDICAL RECORDER, VIEW STATION, DUP[[LICATION STATION
K945460
Philips Medical Systems North America, Inc.
Radiology · 127d
Cleared Feb 24, 1995
FLUOROPLUA CARDIAC AND/OR INSTAVIEW
K941917
Fidelity Medical, Inc.
Radiology · 311d
Cleared Feb 01, 1995
MODEL FP-100
K942019
International Medical Designs, Inc.
Radiology · 281d
Cleared Dec 27, 1994
VISUALIZER 2000
K943272
Vf-Works, Inc.
Radiology · 173d
Cleared Dec 14, 1994
NRF SYSTEM
K944973
Philips Medical Systems (Cleveland), Inc.
Radiology · 64d
Cleared Dec 07, 1994
PANORAMIC CORPORATION HDLX
K943532
Panoramic Corp.
Radiology · 139d
Cleared Nov 28, 1994
V-MAX OPTIONS
K943447
Philips Medical Systems (Cleveland), Inc.
Radiology · 133d
Cleared Sep 23, 1994
PRESTIGE REMOTE R & F SYSTEM MODELS H, VH & VHD
K943805
General Electric Co.
Radiology · 50d
Cleared Aug 22, 1994
UROVIEW MODEL 2600
K940295
Ge Dec Medical Systems
Radiology · 213d
Cleared Aug 09, 1994
OEC 901
K942841
Baldwin
Radiology · 54d
Cleared Jul 29, 1994
ANGIOREST TABLE PAD SYSTEM
K942674
Scribner Browne Medical Design, Inc.
Radiology · 53d
Cleared Jul 20, 1994
DDR WITH DPA AND 30/60 OPTIONS (DIGITAL VIEWSTATION)
K942264
Eigen Video
Radiology · 72d
Cleared May 13, 1994
TDA-4000/A4
K941611
Toshiba America Medical Systems, In.C
Radiology · 39d
Cleared May 09, 1994
EPIC (ELECTROPHYSIOLOGY IMAGING COMPUTER
K926560
Fischer Imaging Corp.
Radiology · 494d
Cleared Feb 07, 1994
SHIMADZU DIGITAL SUBSTRACTION SYST DAR-2400 SERIES
K933472
Shimadzu Corp.
Radiology · 207d
Cleared Jan 25, 1994
UROVIEW SYSTEMS TOMOGRAPHY OPTION SOFTWARE
K936136
Ge Dec Medical Systems
Radiology · 34d
Cleared Nov 24, 1993
CATHETERIZATION C-ARM SUPPORT MH-51BM/MH-51CM
K933473
Shimadzu Corp.
Radiology · 132d
Cleared Nov 22, 1993
PHILIPS ANGIOPRO RELEASE 2.1
K933791
Philips Medical Systems North America, Inc.
Radiology · 110d