510(k) K221592 ยท OEB Lung Computed Tomography System, Computer-Aided Detection
AVIEW Lung Nodule CAD
| Applicant | Coreline Soft Co., Ltd., Seoul, KR |
| Decision | Substantially Equivalent, Feb 24, 2023 |
| Received | Jun 2, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K221592
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.