K954161 is an FDA 510(k) clearance for the JPI INTENSIFYING SCREEN. This device is classified as a Screen, Intensifying, Radiographic (Class I - General Controls, product code EAM).
Submitted by Jpi Healthcare Co, Ltd. (Bayside, US). The FDA issued a Cleared decision on February 2, 1996, 150 days after receiving the submission on September 5, 1995.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1960.
| 510(k) Number | K954161 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 05, 1995 |
| Decision Date | February 02, 1996 |
| Days to Decision | 150 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Statement |
| Product Code | EAM - Screen, Intensifying, Radiographic |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 892.1960 |