K984545 is an FDA 510(k) clearance for the RELEASE 2 OF PHILIPS INTEGRIS SERIES (V5000, BV5000, H5000, BH5000, HM2000) SYSTEMS. 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. (Da Best, NL). The FDA issued a Cleared decision on February 25, 1999, 65 days after receiving the submission on December 22, 1998.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1600.
| 510(k) Number | K984545 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 22, 1998 |
| Decision Date | February 25, 1999 |
| Days to Decision | 65 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 |