510(k) K170858 ยท IZL System, X-Ray, Mobile
FDR AQRO (DR-XD 1000)
| Applicant | Fujifilm Medical Systems U.S.A, Inc., Stamford CT, US |
| Decision | Substantially Equivalent, Apr 24, 2017 |
| Received | Mar 22, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K170858
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 25, 2024 | FUJIFILM Healthcare Americas Corporation The device is a mobile x-ray system designed to work with Fujifilm's GOS and CsI scintillator FDR D-EVO2 (DR-ID) 12XXSE) family of digital x-ray detectors coupled. Open, Classified |
IZL | None listed |
| Apr 27, 2023 | FUJIFILM Healthcare Americas Corporation FujiFilm FDR AQRO (Model DR-XD1000)- A digital mobile X-ray system intended for use in general purpose radiography for generating radiographic images of human anatomy, including adult, pediatric, and Open, Classified |
IZL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.