510(k) K211257 ยท LLZ System, Image Processing, Radiological
EFAI PACS Picture Archiving and Communication System
| Applicant | Ever Fortune.Ai, Co., Ltd., Taichung City, TW |
| Decision | Substantially Equivalent, Sep 10, 2021 |
| Received | Apr 26, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K211257
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.