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 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 16, 2003 | Siemens Medical Solutions USA, Inc. ICON 9.5 Software used on the ICON workstations designed for use with the E.CAM Emission Imaging Computed Tomography Systems; Siemens Medical Systems, Inc., Nuclear Medicine Group, Hoffman Estates, IL Terminated |
JWM | K903315 K914350 |
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