K951176 is an FDA 510(k) clearance for the KOORDINAT M. This device is classified as a Table, Radiographic, Tilting (Class II - Special Controls, product code IXR).
Submitted by Siemens Medical Solutions USA, Inc. (Iselin, US). The FDA issued a Cleared decision on April 20, 1995, 36 days after receiving the submission on March 15, 1995.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1980.
| 510(k) Number | K951176 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 15, 1995 |
| Decision Date | April 20, 1995 |
| Days to Decision | 36 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | IXR — Table, Radiographic, Tilting |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1980 |