K935046 is an FDA 510(k) clearance for the GX-770 X-RAY CONTROL, MODEL 46-404600G4. This device is classified as a Unit, X-ray, Extraoral With Timer (Class II - Special Controls, product code EHD).
Submitted by Gendex Corp. (Des Plaines, US). The FDA issued a Cleared decision on February 18, 1994, 121 days after receiving the submission on October 20, 1993.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 872.1800.
| 510(k) Number | K935046 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 20, 1993 |
| Decision Date | February 18, 1994 |
| Days to Decision | 121 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Statement |
| Product Code | EHD — Unit, X-ray, Extraoral With Timer |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.1800 |