The following data is part of a premarket notification filed by Fujifilm Medical Systems U.s.a., Inc. with the FDA for Fdx Console (dr-id300cl) Software.
| Device ID | K170451 |
| 510k Number | K170451 |
| Device Name: | FDX Console (DR-ID300CL) Software |
| Classification | System, Image Processing, Radiological |
| Applicant | FUJIFILM Medical Systems U.S.A., Inc. 419 West Avenue Stamford, CT 06902 |
| Contact | Peter Altman |
| Correspondent | Peter Altman FUJIFILM Medical Systems U.S.A., Inc. 419 West Avenue Stamford, CT 06902 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-02-15 |
| Decision Date | 2017-03-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04547410316865 | K170451 | 000 |