System, Tomographic, Nuclear

FDA product code JWM · Class II (moderate risk) · 21 CFR 892.1310 · Radiology

17510(k) clearances
0PMA approvals
0recalls

Manufacturers

510(k) clearances

510(k)DeviceApplicantDecision
K914350Icon Computer SystemJWM · Traditional Siemens Gammasonics, Inc.11/22/1991SE
K904599D2 Spectrum Gamma Camera/Crystal V Computer SystemJWM · Traditional Digital Design, Inc.04/23/1991SE
K903315IconJWM · Traditional Siemens Gammasonics, Inc.01/09/1991SE
K901545GCA-9300 Nuclear Tomography SystemJWM · Traditional Toshiba America Medical Systems, In.C06/26/1990SE
K874473Adac Model Arc-St, PC Style Data Processing SystemJWM · Traditional Adac Laboratories07/18/1988SE
K873075Adac Model ARC-5000, Gamma CameraJWM · Traditional Adac Laboratories10/30/1987SE
K851685Digital Gamma Camera Gca 601 EJWM · Traditional Toshiba Medical Systems06/14/1985SE
K850885Starcam Data Acquisition & Processing Sys H3300CJWM · Traditional General Electric Co.06/06/1985SE
K851687Jumbo Digital Gammacamera GCA-90BJWM · Traditional Toshiba Medical Systems06/05/1985SE
K851686Digital Gamma Camera Gca 501SJWM · Traditional Toshiba Medical Systems06/05/1985SE
K841905Dot-A, Dot-Ar Pxp-E, Pxp-ErJWM · Traditional Siemens Gammasonics, Inc.08/09/1984SE
K832737Ect ProcessorJWM · Traditional Siemens Gammasonics, Inc.09/29/1983SE
K812966400T Ect SoftwareJWM · Traditional General Electric Co.11/24/1981SE
K810873StarJWM · Traditional Intl. General Electric Co.04/23/1981SE
K801917StarJWM · Traditional General Electric Co.09/16/1980SE
K780369Modumed MugeJWM · Traditional Medtronic Vascular03/14/1978SE
K780368Modumed MugxJWM · Traditional Medtronic Vascular03/14/1978SE