510(k) K173478 ยท JAK System, X-Ray, Tomography, Computed
OnSight 3D Extremity System
| Applicant | Carestream Health, Inc., Rochester NY, US |
| Decision | Substantially Equivalent, Jan 19, 2018 |
| Received | Nov 13, 2017 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K173478
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 19, 2019 | Carestream Health, Inc. OnSight 3D Extremity System- X-Ray, Tomography Computed System
Catalog Numbers:
1743566 (w/ Attached Console)
1743574 (w/ Remote Console)
The device is intended to be used for x-ray computed tomograp Terminated |
JAK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.