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
25–48 of 130
Cleared Jan 15, 1993
NEW DETECTOR FOR TRANSCAM/POLARIS S315
K924639
Adac Laboratories
Radiology · 135d
Cleared Jan 15, 1993
NEW DETECTOR OPTION
K924878
Adac Laboratories
Radiology · 136d
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 Mar 25, 1991
ES/ULTRA DISPLAY AND PROCESSING STATION
K905412
Toshiba America Medical Systems, In.C
Radiology · 112d
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 Apr 19, 1990
MODIFIED ADAC NUCLEAR MEDICINE GAMMA CAMERA
K900689
Adac Laboratories
Radiology · 65d
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 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
Cleared Mar 31, 1987
JUMBO DIGITAL GAMMACAMERA, GCA-901A
K871175
Toshiba Medical Systems
Radiology · 7d
Cleared Mar 16, 1987
BODYSCAN
K870818
Siemens Gammasonics, Inc.
Radiology · 13d
Cleared Jun 10, 1986
WEIGHTED ACQUISITION MODULE
K861637
Siemens Gammasonics, Inc.
Radiology · 41d
Cleared Jan 30, 1986
STARPORT MODEL H3300AA
K852648
General Electric Co.
Radiology · 223d
Cleared Nov 19, 1985
JUMBO DIGITAL GAMMACAMERA GCA-90B WI & W2
K853470
Toshiba Medical Systems
Radiology · 92d
Cleared Jul 18, 1985
SATURN NUCLEAR MEDICINE COMPUTER SYSTEM
K852089
Technicare Corp.
Radiology · 66d
Cleared Apr 10, 1985
BASICAM COUNTER BALANCE CAMERA
K850463
Siemens Gammasonics, Inc.
Radiology · 63d
Cleared Mar 26, 1985
ORBITOR II COUNTER BALANCE CAMERA
K850397
Siemens Gammasonics, Inc.
Radiology · 53d