K921101 is an FDA 510(k) clearance for the PHILIPS INTEGRIS V3000 FILM. This device is classified as a System, X-ray, Angiographic (Class II - Special Controls, product code IZI).
Submitted by Philips Medical Systems, Inc. (5680 Da Best, NL). The FDA issued a Cleared decision on May 15, 1992, 67 days after receiving the submission on March 9, 1992.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1600.
| 510(k) Number | K921101 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 09, 1992 |
| Decision Date | May 15, 1992 |
| Days to Decision | 67 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | IZI — System, X-ray, Angiographic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1600 |