The following data is part of a premarket notification filed by Fujifilm Medical Systems U.s.a., Inc. with the FDA for Fujifilm Fcr View, Model Cr-vw674.
| Device ID | K081308 |
| 510k Number | K081308 |
| Device Name: | FUJIFILM FCR VIEW, MODEL CR-VW674 |
| Classification | System, Image Processing, Radiological |
| Applicant | FUJIFILM MEDICAL SYSTEMS U.S.A., INC. 419 WEST AVE. Stamford, CT 06902 -6300 |
| Contact | Debra A Peacock |
| Correspondent | Debra A Peacock FUJIFILM MEDICAL SYSTEMS U.S.A., INC. 419 WEST AVE. Stamford, CT 06902 -6300 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-05-09 |
| Decision Date | 2008-06-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04547410316926 | K081308 | 000 |