Device, Spot-Film
Regulation 892.1670
0510(k)s in 12 months (13 all time)
0recalls in 12 months (3 all time)
3recalls that name a 510(k)
Top companies in IXL
| Company | 510(k)s | Recalls |
|---|---|---|
| Philips Medical Systems North America Co. Phillips | 0 | 3 |
| Applied X-Ray Technologies, Inc. | 2 | 0 |
| GE Medical Systems | 2 | 0 |
| Rms Div. | 2 | 0 |
| Continental X-Ray Corp. | 1 | 0 |
| Eastman Kodak Company | 1 | 0 |
| Fischer Imaging Corp. | 1 | 0 |
| General Electric Co. | 1 | 0 |
| Machlett Laboratories, Inc. | 1 | 0 |
| Philips Medical Systems, Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 8, 2011 | Philips Medical Systems North America Co. Phillips Philips BV Pulsera, Rel. 2.3, 718095.
Mobile C-Arm X-Ray systems offering Radiographic and Fluoroscopic techniques in a wide variety of applications. Terminated |
IXL | K010435 |
| Mar 8, 2011 | Philips Medical Systems North America Co. Phillips Philips BV Endura, Rel. 2, 718074.
Mobile C-Arm X-Ray systems offering Radiographic and Fluoroscopic techniques in a wide variety of applications. Terminated |
IXL | K010435 |
| Sep 13, 2010 | Philips Medical Systems North America Co. Phillips Diagnost 56/66/76/76 Plus, DSI is a Spot-Film and has a Digital Imaging Spot.
Intended use is for the following applications: as a multifunctional/universal system, general R/F, Fluoroscopy, Radiolo Terminated |
IXL | K924593 |
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