K920793 is an FDA 510(k) clearance for the PHILIPS DSI SYSTEM RELEASE 3.2. This device is classified as a Camera, X-ray, Fluorographic, Cine Or Spot (Class II - Special Controls, product code IZJ).
Submitted by Philips Medical Systems, Inc. (5680 Da Best, NL). The FDA issued a Cleared decision on July 17, 1992, 147 days after receiving the submission on February 21, 1992.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1620.
| 510(k) Number | K920793 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 21, 1992 |
| Decision Date | July 17, 1992 |
| Days to Decision | 147 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | IZJ — Camera, X-ray, Fluorographic, Cine Or Spot |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1620 |