K924443 is an FDA 510(k) clearance for the RS-3 UNIVERSAL RADIOGRAPHIC WORKING PLACE. This device is classified as a System, X-ray, Tomographic (Class II - Special Controls, product code IZF).
Submitted by Control-X, Inc. (Columbus, US). The FDA issued a Cleared decision on February 5, 1993, 157 days after receiving the submission on September 1, 1992.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1740.
| 510(k) Number | K924443 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 01, 1992 |
| Decision Date | February 05, 1993 |
| Days to Decision | 157 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Statement |
| Product Code | IZF — System, X-ray, Tomographic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1740 |