K943822 is an FDA 510(k) clearance for the FUJI UM MAMMO SERIES INTENSIFY SCREENS:. This device is classified as a Screen, Intensifying, Radiographic (Class I - General Controls, product code EAM).
Submitted by Fujifilm Medical System U.S.A., Inc. (Stamford, US). The FDA issued a Cleared decision on August 22, 1994, 68 days after receiving the submission on June 15, 1994.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1960.
| 510(k) Number | K943822 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 15, 1994 |
| Decision Date | August 22, 1994 |
| Days to Decision | 68 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | EAM — Screen, Intensifying, Radiographic |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 892.1960 |