510(k) K213307 ยท MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Eclipse II with Smart Noise Cancellation
| Applicant | Carestream Health, Inc., Rochester NY, US |
| Decision | Substantially Equivalent, Jan 14, 2022 |
| Received | Oct 4, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K213307
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.