K914351 is an FDA 510(k) clearance for the CLINITRON C-10. This device is classified as a Table, Radiographic, Stationary Top (Class II - Special Controls, product code IXQ).
Submitted by Ssi Medical Services, Inc. (Chicago, US). The FDA issued a Cleared decision on February 14, 1992, 140 days after receiving the submission on September 27, 1991.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1980.
| 510(k) Number | K914351 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 27, 1991 |
| Decision Date | February 14, 1992 |
| Days to Decision | 140 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Statement |
| Product Code | IXQ — Table, Radiographic, Stationary Top |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1980 |