K920189 is an FDA 510(k) clearance for the GX-C CEPHALOMETER. This device is classified as a Cephalometer (Class II - Special Controls, product code EAG).
Submitted by Gendex Corp. (Des Plaines, US). The FDA issued a Cleared decision on April 28, 1992, 104 days after receiving the submission on January 15, 1992.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 872.1830.
| 510(k) Number | K920189 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 15, 1992 |
| Decision Date | April 28, 1992 |
| Days to Decision | 104 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Statement |
| Product Code | EAG — Cephalometer |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.1830 |