The following data is part of a premarket notification filed by Fujifilm Medical Systems U.s.a., Inc. with the FDA for Fdr Aqro (dr-xd 1000).
| Device ID | K170858 |
| 510k Number | K170858 |
| Device Name: | FDR AQRO (DR-XD 1000) |
| Classification | System, X-ray, Mobile |
| 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 | IZL |
| CFR Regulation Number | 892.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-03-22 |
| Decision Date | 2017-04-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04547410425505 | K170858 | 000 |
| 04547410339352 | K170858 | 000 |
| 04547410339215 | K170858 | 000 |
| 04547410339161 | K170858 | 000 |