The following data is part of a premarket notification filed by Fujifilm Medical System U.s.a., Inc. with the FDA for Fuji Medical Dry Imager Fm-dp 2636.
| Device ID | K962967 |
| 510k Number | K962967 |
| Device Name: | FUJI MEDICAL DRY IMAGER FM-DP 2636 |
| Classification | Camera, Multi Format, Radiological |
| 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 | LMC |
| CFR Regulation Number | 892.2040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-07-30 |
| Decision Date | 1996-10-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04547410207767 | K962967 | 000 |
| 04547410207743 | K962967 | 000 |
| 04547410207699 | K962967 | 000 |
| 14547410080794 | K962967 | 000 |
| 14547410080770 | K962967 | 000 |
| 14547410080558 | K962967 | 000 |
| 14547410080527 | K962967 | 000 |