The following data is part of a premarket notification filed by Fujifilm Medical System U.s.a., Inc. with the FDA for Fuji Computed Radiograp Hi-c654 Dms Crt Image Cons.
| Device ID | K931002 |
| 510k Number | K931002 |
| Device Name: | FUJI COMPUTED RADIOGRAP HI-C654 DMS CRT IMAGE CONS |
| Classification | System, Imaging, X-ray, Electrostatic |
| 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 | IXK |
| CFR Regulation Number | 892.1630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-02-26 |
| Decision Date | 1993-06-08 |