K931882 is an FDA 510(k) clearance for the MAMMO-300 AUTOMATIC X-RAY FILM PROCESSOR. This device is classified as a Processor, Radiographic-film, Automatic (Class II - Special Controls, product code IXW).
Submitted by Alphatek Corp. (Chicago, US). The FDA issued a Cleared decision on August 23, 1993, 131 days after receiving the submission on April 14, 1993.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1900.
| 510(k) Number | K931882 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 14, 1993 |
| Decision Date | August 23, 1993 |
| Days to Decision | 131 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Statement |
| Product Code | IXW — Processor, Radiographic-film, Automatic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1900 |