K901014 is an FDA 510(k) clearance for the RADIOGRAPHIC INTENSIFYING SCREEN. This device is classified as a Screen, Intensifying, Radiographic (Class I - General Controls, product code EAM).
Submitted by Infab Corp. (Camarillo, US). The FDA issued a Cleared decision on April 2, 1990, 28 days after receiving the submission on March 5, 1990.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1960.
| 510(k) Number | K901014 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 05, 1990 |
| Decision Date | April 02, 1990 |
| Days to Decision | 28 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | — |
| Product Code | EAM — Screen, Intensifying, Radiographic |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 892.1960 |