IYX · Class I · 21 CFR 892.1100

FDA Product Code IYX: Camera, Scintillation (gamma)

Leading manufacturers include General Electric Co., Siemens Gammasonics, Inc. and Adac Laboratories.

130
Total
130
Cleared
92d
Avg days
1976
Since
130 devices
49–72 of 130
Cleared May 28, 1992
ADAC S315
K921296
Adac Laboratories
Radiology · 72d
Cleared Jul 03, 1991
NEUROCAM
K910967
GE Medical Systems
Radiology · 119d
Cleared Jun 21, 1991
MICRODELTA, TC-99M-MAG3 RENAL PROCESSING PROGRAM
K905074
Siemens Gammasonics, Inc.
Radiology · 224d
Cleared Apr 18, 1991
SOPHYCAMERA DSX BODYTRAK
K911346
Sopha Medical Systems, Inc.
Radiology · 22d
Cleared Mar 25, 1991
ES/ULTRA DISPLAY AND PROCESSING STATION
K905412
Toshiba America Medical Systems, In.C
Radiology · 112d
Cleared Feb 04, 1991
GAMMA 600 NUCLEAR MEDICINE COMPUTER
K903469
Strichman Medical Equipment, Inc.
Radiology · 187d
Cleared Jan 28, 1991
FULL VIEW OMEGA TABLE
K905827
Med-Tron Products, Inc.
Radiology · 28d
Cleared Jan 04, 1991
STARCAM 4000
K904174
General Electric Co.
Radiology · 116d
Cleared Dec 05, 1990
MODEL DH-1000 SINGLE DETEC./DUAL DETEC NUCL CAMERA
K904050
Philips Medical Systems (Cleveland), Inc.
Radiology · 92d
Cleared Oct 29, 1990
SOPHYCAMERA DSM 315
K903030
Provino
Radiology · 111d
Cleared Oct 23, 1990
PANORAMIC OMEGA IMAGING TABLE
K903988
Med-Tron Products, Inc.
Radiology · 55d
Cleared May 23, 1990
NUCLEAR MAX
K900773
Scientific Imaging, Inc.
Radiology · 96d
Cleared Apr 19, 1990
MODIFIED ADAC NUCLEAR MEDICINE GAMMA CAMERA
K900689
Adac Laboratories
Radiology · 65d
Cleared Oct 27, 1989
SOPHYCAMERA DSX RECTANGULAR
K894931
Sopha Medical Systems, Inc.
Radiology · 86d
Cleared Aug 11, 1989
XENOS MOBILECAM
K893379
Xenos Medical Systems, Inc.
Radiology · 102d
Cleared Apr 19, 1989
SYSTEM SEVENTY SEVEN
K885054
Scinticor, Inc.
Radiology · 133d
Cleared Apr 17, 1989
APEX 115 NUCLEAR MEDICINE PROCESSOR
K884672
Elscint, Inc.
Radiology · 160d
Cleared Apr 17, 1989
APEX 415 ANGER CAMERA
K884674
Elscint, Inc.
Radiology · 160d
Cleared Apr 17, 1989
APEX 609R ANGER CAMERA
K884675
Elscint, Inc.
Radiology · 160d
Cleared Apr 14, 1989
APEX 215M MOBILE ANGER CAMERA
K884673
Elscint, Inc.
Radiology · 157d
Cleared Apr 12, 1989
D-SCOPE III
K884661
Medx, Inc.
Radiology · 156d
Cleared Mar 30, 1989
MICRODELTA II
K885242
Siemens Gammasonics, Inc.
Radiology · 98d
Cleared Sep 01, 1988
CX250 MOBILE GAMMA CAMERA & DCS CONSOLE
K880878
Philips Medical Systems (Cleveland), Inc.
Radiology · 184d
Cleared Aug 29, 1988
MULTIPURPOSE DIGITAL GAMMACAMERA, GCA-602A
K881013
Toshiba Medical Systems
Radiology · 172d