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 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 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
Cleared Mar 01, 1985
TOMOGRAPHIC GANTRY
K844218
General Electric Co.
Radiology · 121d
Cleared Jul 06, 1984
MAXICAMERA 400 AC
K841906
General Electric Co.
Radiology · 59d
Cleared Mar 22, 1984
DIGITAL PROCESSING SYSTEM
K840052
Adac Laboratories
Radiology · 76d
Cleared Dec 27, 1983
CARDIAC CAMERA
K833811
Siemens Gammasonics, Inc.
Radiology · 104d
Cleared Mar 02, 1982
ADD'L TERMINAL SUPPORT FOR STAR BASIC
K820244
General Electric Co.
Radiology · 32d
Cleared Sep 08, 1981
DYNA- MO
K811629
Philips Medical Systems (Cleveland), Inc.
Radiology · 91d
Cleared Jul 20, 1981
ROTA CAMERA
K811715
Siemens Gammasonics, Inc.
Radiology · 32d
Cleared Jul 02, 1981
MAXI CAMERA/D
K811676
General Electric Co.
Radiology · 17d
Cleared May 27, 1981
MEDTRONIC A2 CLINICAL IMAGING SYSTEM
K811187
Medtronic Vascular
Radiology · 28d
Cleared May 13, 1981
GAMMA CAMERA
K810974
Siemens Gammasonics, Inc.
Radiology · 33d
Cleared Nov 26, 1980
A2 IMAGE PROCESSING SYSTEM
K802475
Medtronic Vascular
Radiology · 48d
Cleared Aug 20, 1980
MAXI CAMERA 37
K801653
General Electric Co.
Radiology · 33d
Cleared Aug 20, 1980
MAXI CAMERA 61
K801654
General Electric Co.
Radiology · 33d
Cleared Jul 21, 1980
A2 IMAGE PROCESSING SYSTEM
K801368
Medtronic Vascular
Radiology · 41d
Cleared Dec 13, 1979
CLEON 720 LARGE FIELD GAMMA CAMERA
K791682
Union Carbide Corp.
Radiology · 107d