JWM · Class II · 21 CFR 892.1310

FDA Product Code JWM: System, Tomographic, Nuclear

Leading manufacturers include Siemens Gammasonics, Inc., General Electric Co. and Toshiba Medical Systems.

17
Total
17
Cleared
78d
Avg days
1978
Since

FDA 510(k) Cleared System, Tomographic, Nuclear Devices (Product Code JWM)

17 devices
1–17 of 17
Cleared Nov 22, 1991
ICON COMPUTER SYSTEM
K914350
Siemens Gammasonics, Inc.
Radiology · 56d
Cleared Apr 23, 1991
D2 SPECTRUM GAMMA CAMERA/CRYSTAL V COMPUTER SYSTEM
K904599
Digital Design, Inc.
Radiology · 195d
Cleared Jan 09, 1991
ICON
K903315
Siemens Gammasonics, Inc.
Radiology · 169d
Cleared Jun 26, 1990
GCA-9300 NUCLEAR TOMOGRAPHY SYSTEM
K901545
Toshiba America Medical Systems, In.C
Radiology · 84d
Cleared Jul 18, 1988
ADAC MODEL ARC-ST, PC STYLE DATA PROCESSING SYSTEM
K874473
Adac Laboratories
Radiology · 259d
Cleared Oct 30, 1987
ADAC MODEL ARC-5000, GAMMA CAMERA
K873075
Adac Laboratories
Radiology · 85d
Cleared Jun 14, 1985
DIGITAL GAMMA CAMERA GCA 601 E
K851685
Toshiba Medical Systems
Radiology · 52d
Cleared Jun 06, 1985
STARCAM DATA ACQUISITION & PROCESSING SYS H3300C
K850885
General Electric Co.
Radiology · 94d
Cleared Jun 05, 1985
DIGITAL GAMMA CAMERA GCA 501S
K851686
Toshiba Medical Systems
Radiology · 43d
Cleared Jun 05, 1985
JUMBO DIGITAL GAMMACAMERA GCA-90B
K851687
Toshiba Medical Systems
Radiology · 43d
Cleared Aug 09, 1984
DOT-A, DOT-AR PXP-E, PXP-ER
K841905
Siemens Gammasonics, Inc.
Radiology · 94d
Cleared Sep 29, 1983
ECT PROCESSOR
K832737
Siemens Gammasonics, Inc.
Radiology · 49d
Cleared Nov 24, 1981
400T ECT SOFTWARE
K812966
General Electric Co.
Radiology · 33d
Cleared Apr 23, 1981
STAR
K810873
Intl. General Electric Co.
Radiology · 23d
Cleared Sep 16, 1980
STAR
K801917
General Electric Co.
Radiology · 36d
Cleared Mar 14, 1978
MODUMED MUGX
K780368
Medtronic Vascular
Radiology · 7d
Cleared Mar 14, 1978
MODUMED MUGE
K780369
Medtronic Vascular
Radiology · 7d

About Product Code JWM - Regulatory Context