K024342 is an FDA 510(k) clearance for the RADIOGRAPHIC FILM PROCESSOR, MODELS XP400 AND XP1000. This device is classified as a Processor, Radiographic-film, Automatic (Class II - Special Controls, product code IXW).
Submitted by Daito Co., Ltd. (Manchester, US). The FDA issued a Cleared decision on April 23, 2003, 117 days after receiving the submission on December 27, 2002.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1900.
| 510(k) Number | K024342 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 27, 2002 |
| Decision Date | April 23, 2003 |
| Days to Decision | 117 days |
| Submission Type | Traditional |
| 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 |