K925302 is an FDA 510(k) clearance for the PHILIPS INTEGRIS H/HM SYSTEM. This device is classified as a System, X-ray, Tomographic (Class II - Special Controls, product code IZF).
Submitted by Philips Medical Systems, Inc. (5680 Da Best, NL). The FDA issued a Cleared decision on December 17, 1992, 57 days after receiving the submission on October 21, 1992.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1740.
| 510(k) Number | K925302 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 21, 1992 |
| Decision Date | December 17, 1992 |
| Days to Decision | 57 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Statement |
| Product Code | IZF — System, X-ray, Tomographic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1740 |