K023801 is an FDA 510(k) clearance for the FILM PROCESSOR, MODEL LIFE RAY PRO 1000. This device is classified as a Processor, Radiographic-film, Automatic (Class II - Special Controls, product code IXW).
Submitted by S.A.I.E.P. S.R.L. (Weatherford, US). The FDA issued a Cleared decision on February 12, 2003, 90 days after receiving the submission on November 14, 2002.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1900.
| 510(k) Number | K023801 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 14, 2002 |
| Decision Date | February 12, 2003 |
| Days to Decision | 90 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 |