Camera, X-Ray, Fluorographic, Cine Or Spot
Regulation 892.1620
0510(k)s in 12 months (12 all time)
0recalls in 12 months (2 all time)
2recalls that name a 510(k)
Top companies in IZJ
| Company | 510(k)s | Recalls |
|---|---|---|
| Philips Medical Systems (Cleveland), Inc. | 1 | 1 |
| Siemens Corp. | 2 | 0 |
| Adac Laboratories | 1 | 0 |
| Canon USA, Inc. | 1 | 0 |
| Diversified P.A. | 1 | 0 |
| Fairmontmedical | 1 | 0 |
| Instrumentation Camera, Inc. | 1 | 0 |
| Perkins Electronics Co. | 1 | 0 |
| Perkins Mfg. Co. | 1 | 0 |
| Philips Medical Systems, Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 17, 2014 | Philips Medical Systems (Cleveland) Inc ADAC ARGUS Gamma Camera Systems & ADAC CIRRUS Gamma Camera Systems. Distributed by Philips Medical Systems, Cleveland, OH Terminated |
IZJ | K913471 |
| Aug 25, 2008 | Philips Medical Systems North America Co. Phillips General X-Ray System types with Digital Spot Imaging (DSI) software Terminated |
IZJ | K920793 |
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