K924430 is an FDA 510(k) clearance for the AX-300SE AUTOMATIC X-RAY FILM PROCESSOR, 6586.027. 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 November 27, 1992, 87 days after receiving the submission on September 1, 1992.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1900.
| 510(k) Number | K924430 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 01, 1992 |
| Decision Date | November 27, 1992 |
| Days to Decision | 87 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 |