K950043 is an FDA 510(k) clearance for the JPI AUTOMATIC X-RAY FILM PROCESSOR. This device is classified as a Processor, Radiographic-film, Automatic (Class II - Special Controls, product code IXW).
Submitted by Jpi Healthcare Co, Ltd. (Bayside, US). The FDA issued a Cleared decision on May 10, 1995, 125 days after receiving the submission on January 5, 1995.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1900.
| 510(k) Number | K950043 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 05, 1995 |
| Decision Date | May 10, 1995 |
| Days to Decision | 125 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 |