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
73–96 of 130
Cleared Jul 14, 1988
MODEL 3000 NUCLEAR CAMERA
K882312
Ohio Imaging, Inc.
Radiology · 41d
Cleared Jul 01, 1988
DIGITAL NUCLEAR IMAGING SYSTEM
K875198
Medasys, Inc.
Radiology · 197d
Cleared Aug 12, 1987
DS-7 NUCLEAR MEDICINE GAMMA CAMERA
K872297
Sopha Medical Systems, Inc.
Radiology · 57d
Cleared Jun 18, 1987
D-SCOPE II AND D-SCOPE IIC
K872127
Medx, Inc.
Radiology · 16d
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 Feb 26, 1987
SKAN D-SCOPE
K870703
Medx, Inc.
Radiology · 6d
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 Jan 01, 1986
ACE COMPUTER SYSTEM
K853482
Cardiac Medical Systems Corp.
Radiology · 134d
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 May 21, 1985
SPECTRUM 150 DT
K851644
Raytheon Medical Systems
Radiology · 32d
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 Dec 17, 1984
NUCLEAR 700 MEDICINE MECHANICAL POSIT-
K843716
Technicare Corp.
Radiology · 84d
Cleared Nov 13, 1984
DELTANODE, MEGA DELTA, DELTA LINK-
K843558
Computer Design & Applications, Inc.
Radiology · 64d
Cleared Nov 08, 1984
KETRONIC MEDAX - N
K843288
Ketronic, Inc.
Radiology · 79d
Cleared Aug 21, 1984
MICRO DELTA & CELTAPRO
K841964
Computer Design & Applications, Inc.
Radiology · 99d
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 Jan 13, 1984
INTERAD 520
K833821
Interad Systems, Inc.
Radiology · 72d
Cleared Dec 27, 1983
CARDIAC CAMERA
K833811
Siemens Gammasonics, Inc.
Radiology · 104d