K911098 is an FDA 510(k) clearance for the PHILIPS URO DIAGNOST MRF. This device is classified as a Table, Radiographic, Tilting (Class II - Special Controls, product code IXR).
Submitted by Philips Medical Systems, Inc. (5680 Da Best, NL). The FDA issued a Cleared decision on July 3, 1991, 113 days after receiving the submission on March 12, 1991.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1980.
| 510(k) Number | K911098 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 12, 1991 |
| Decision Date | July 03, 1991 |
| Days to Decision | 113 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | — |
| Product Code | IXR — Table, Radiographic, Tilting |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1980 |