The following data is part of a premarket notification filed by Fujifilm Medical System U.s.a., Inc. with the FDA for Fuji Medical Cr Console, Model Flash Iip.
| Device ID | K041990 |
| 510k Number | K041990 |
| Device Name: | FUJI MEDICAL CR CONSOLE, MODEL FLASH IIP |
| Classification | System, Image Processing, Radiological |
| Applicant | FUJIFILM MEDICAL SYSTEM U.S.A., INC. 419 WEST AVE. Stamford, CT 06902 |
| Contact | Frank Gianelli |
| Correspondent | William Sammons UNDERWRITERS LABORATORIES, INC. 12 LABORATORY DR. Research Triangle, NC 27709 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2004-07-23 |
| Decision Date | 2004-08-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04547410333527 | K041990 | 000 |
| 04547410316872 | K041990 | 000 |
| 04547410316865 | K041990 | 000 |