K992896 is an FDA 510(k) clearance for the DXSS AUTOMATIC X-RAY FILM PROCESSOR, (MODELS #S: 512, 1530, 812, 830). This device is classified as a Processor, Radiographic-film, Automatic, Dental (Class II - Special Controls, product code EGY).
Submitted by Dental X-Ray Support Systems, Inc. (Lynnwood, US). The FDA issued a Cleared decision on September 3, 1999, 7 days after receiving the submission on August 27, 1999.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1900.
| 510(k) Number | K992896 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 27, 1999 |
| Decision Date | September 03, 1999 |
| Days to Decision | 7 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | EGY — Processor, Radiographic-film, Automatic, Dental |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1900 |