K002640 is an FDA 510(k) clearance for the FREEDOM AUTOMATIC FILM PROCESSOR. This device is classified as a Processor, Radiographic-film, Automatic (Class II - Special Controls, product code IXW).
Submitted by J. Morita USA, Inc. (Irvine, US). The FDA issued a Cleared decision on November 8, 2000, 76 days after receiving the submission on August 24, 2000.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1900.
| 510(k) Number | K002640 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 24, 2000 |
| Decision Date | November 08, 2000 |
| Days to Decision | 76 days |
| Submission Type | Abbreviated |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | IXW — Processor, Radiographic-film, Automatic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1900 |