The following data is part of a premarket notification filed by Fujifilm Medical System U.s.a., Inc. with the FDA for Fujifilm Ec-b Series Casette.
| Device ID | K932565 |
| 510k Number | K932565 |
| Device Name: | FUJIFILM EC-B SERIES CASETTE |
| Classification | Cassette, Radiographic Film |
| Applicant | FUJIFILM MEDICAL SYSTEM U.S.A., INC. 333 LUDLOW ST. P.O. BOX 120035 Stamford, CT 06912 -0035 |
| Contact | Robert Uzenoff |
| Correspondent | Robert Uzenoff FUJIFILM MEDICAL SYSTEM U.S.A., INC. 333 LUDLOW ST. P.O. BOX 120035 Stamford, CT 06912 -0035 |
| Product Code | IXA |
| CFR Regulation Number | 892.1850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-05-27 |
| Decision Date | 1993-07-26 |