K032046 is an FDA 510(k) clearance for the PHILLIPS OMNIDIAGNOST ELEVA. This device is classified as a Interventional Fluoroscopic X-ray System (Class II - Special Controls, product code OWB).
Submitted by Philips Medical Systems, Inc. (Da Best, NL). The FDA issued a Cleared decision on July 17, 2003, 15 days after receiving the submission on July 2, 2003.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1650. Interventional Fluoroscopy.
| 510(k) Number | K032046 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 02, 2003 |
| Decision Date | July 17, 2003 |
| Days to Decision | 15 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | OWB — Interventional Fluoroscopic X-ray System |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1650 |
| Definition | Interventional Fluoroscopy |