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 Laser Imagers, Models Drypix 7000, Drypix 5000 And Fm-dp L.
| Device ID | K033377 |
| 510k Number | K033377 |
| Device Name: | FUJI MEDICAL DRY LASER IMAGERS, MODELS DRYPIX 7000, DRYPIX 5000 AND FM-DP L |
| Classification | Camera, Multi Format, Radiological |
| Applicant | FUJIFILM MEDICAL SYSTEM U.S.A., INC. 419 WEST AVE. Stamford, CT 06902 |
| Contact | Frank Gianelli |
| Correspondent | Frank Gianelli FUJIFILM MEDICAL SYSTEM U.S.A., INC. 419 WEST AVE. Stamford, CT 06902 |
| Product Code | LMC |
| CFR Regulation Number | 892.2040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-10-22 |
| Decision Date | 2004-01-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 14547410265986 | K033377 | 000 |
| 04547410207699 | K033377 | 000 |
| 04547410180077 | K033377 | 000 |
| 04547410180060 | K033377 | 000 |
| 14547410142454 | K033377 | 000 |
| 14547410142430 | K033377 | 000 |
| 14547410080794 | K033377 | 000 |
| 14547410080770 | K033377 | 000 |
| 14547410080558 | K033377 | 000 |
| 04547410207743 | K033377 | 000 |
| 04547410207767 | K033377 | 000 |
| 14547410265962 | K033377 | 000 |
| 04547410239355 | K033377 | 000 |
| 04547410239300 | K033377 | 000 |
| 14547410222576 | K033377 | 000 |
| 14547410222569 | K033377 | 000 |
| 14547410222552 | K033377 | 000 |
| 14547410222545 | K033377 | 000 |
| 14547410222491 | K033377 | 000 |
| 14547410080527 | K033377 | 000 |