K971365 is an FDA 510(k) clearance for the PHILIPS INTEGRIS H5000. This device is classified as a System, X-ray, Angiographic (Class II - Special Controls, product code IZI).
Submitted by Philips Medical Systems North America, Inc. (Shelton, US). The FDA issued a Cleared decision on May 14, 1997, 30 days after receiving the submission on April 14, 1997.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1600.
| 510(k) Number | K971365 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 14, 1997 |
| Decision Date | May 14, 1997 |
| Days to Decision | 30 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 |