K945682 is an FDA 510(k) clearance for the PROCESSOR, RADIOGRAPHIC-FILM, AUTOMATIC, DENTAL. This device is classified as a Processor, Radiographic-film, Automatic, Dental (Class II - Special Controls, product code EGY).
Submitted by Gendex Corp. (Des Plaines, US). The FDA issued a Cleared decision on February 9, 1995, 80 days after receiving the submission on November 21, 1994.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1900.
| 510(k) Number | K945682 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 21, 1994 |
| Decision Date | February 09, 1995 |
| Days to Decision | 80 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Statement |
| Product Code | EGY — Processor, Radiographic-film, Automatic, Dental |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1900 |