The following data is part of a premarket notification filed by Fujifilm Medical System U.s.a., Inc. with the FDA for Fuji Um Mammo Series Intensify Screens:.
| Device ID | K943822 |
| 510k Number | K943822 |
| Device Name: | FUJI UM MAMMO SERIES INTENSIFY SCREENS: |
| Classification | Screen, Intensifying, Radiographic |
| Applicant | FUJIFILM MEDICAL SYSTEM U.S.A., INC. 333 LUDLOW ST. P.O. BOX 120035 Stamford, CT 06912 -0035 |
| Contact | Robert A Uzenoff |
| Correspondent | Robert A Uzenoff FUJIFILM MEDICAL SYSTEM U.S.A., INC. 333 LUDLOW ST. P.O. BOX 120035 Stamford, CT 06912 -0035 |
| Product Code | EAM |
| CFR Regulation Number | 892.1960 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-06-15 |
| Decision Date | 1994-08-22 |