K922591 is an FDA 510(k) clearance for the UROLOGICAL C-ARM TABLE, MODEL #056-450. This device is classified as a Table, Radiographic, Tilting (Class II - Special Controls, product code IXR).
Submitted by Biodan Medical Systems, Ltd. (Shirley, US). The FDA issued a Cleared decision on November 27, 1992, 178 days after receiving the submission on June 2, 1992.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1980.
| 510(k) Number | K922591 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 02, 1992 |
| Decision Date | November 27, 1992 |
| Days to Decision | 178 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Statement |
| Product Code | IXR — Table, Radiographic, Tilting |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1980 |