System, Tomographic, Nuclear
Regulation 892.1310
0510(k)s in 12 months (17 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in JWM
| Company | 510(k)s | Recalls |
|---|---|---|
| Siemens Gammasonics, Inc. | 4 | 0 |
| General Electric Co. | 3 | 0 |
| Toshiba Medical Systems | 3 | 0 |
| Adac Laboratories | 2 | 0 |
| Medtronic Vascular | 2 | 0 |
| Digital Design, Inc. | 1 | 0 |
| Intl. General Electric Co. | 1 | 0 |
| Siemens Medical Solutions USA, Inc. | 0 | 1 |
| Toshiba America Medical Systems, In.C | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 22, 1991 | K914350 | ICON COMPUTER SYSTEM Siemens Gammasonics, Inc. | JWM |
| Apr 23, 1991 | K904599 | D2 SPECTRUM GAMMA CAMERA/CRYSTAL V COMPUTER SYSTEM Digital Design, Inc. | JWM |
| Jan 9, 1991 | K903315 | ICON Siemens Gammasonics, Inc. | JWM |
| Jun 26, 1990 | K901545 | GCA-9300 NUCLEAR TOMOGRAPHY SYSTEM Toshiba America Medical Systems, In.C | JWM |
| Jul 18, 1988 | K874473 | ADAC MODEL ARC-ST, PC STYLE DATA PROCESSING SYSTEM Adac Laboratories | JWM |
| Oct 30, 1987 | K873075 | ADAC MODEL ARC-5000, GAMMA CAMERA Adac Laboratories | JWM |
| Jun 14, 1985 | K851685 | DIGITAL GAMMA CAMERA GCA 601 E Toshiba Medical Systems | JWM |
| Jun 6, 1985 | K850885 | STARCAM DATA ACQUISITION & PROCESSING SYS H3300C General Electric Co. | JWM |
| Jun 5, 1985 | K851687 | JUMBO DIGITAL GAMMACAMERA GCA-90B Toshiba Medical Systems | JWM |
| Jun 5, 1985 | K851686 | DIGITAL GAMMA CAMERA GCA 501S Toshiba Medical Systems | JWM |
| Aug 9, 1984 | K841905 | DOT-A, DOT-AR PXP-E, PXP-ER Siemens Gammasonics, Inc. | JWM |
| Sep 29, 1983 | K832737 | ECT PROCESSOR Siemens Gammasonics, Inc. | JWM |
| Nov 24, 1981 | K812966 | 400T ECT SOFTWARE General Electric Co. | JWM |
| Apr 23, 1981 | K810873 | STAR Intl. General Electric Co. | JWM |
| Sep 16, 1980 | K801917 | STAR General Electric Co. | JWM |
| Mar 14, 1978 | K780369 | MODUMED MUGE Medtronic Vascular | JWM |
| Mar 14, 1978 | K780368 | MODUMED MUGX Medtronic Vascular | JWM |
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