510(k) K201373 ยท KPR System, X-Ray, Stationary
DRX-Compass
| Applicant | Carestream Health, Inc., China (Shanghai) Pilot Free Trade Zone, CN |
| Decision | Substantially Equivalent, Jun 26, 2020 |
| Received | May 26, 2020 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K201373
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 2, 2023 | Carestream Health, Inc. DRX-Compass/DR-FIT X-ray Systems with Firmware version 2.3.2.0/2.3.2.4. For use in obtaining diagnostic quality radiographic images to aid the physician with diagnosis.
CATALOG #(s):
8624181 X-RAY S Open, Classified |
KPR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.