510(k) K254214 ยท LLZ System, Image Processing, Radiological
OOOPDS
| Applicant | Taiwan Main Orthopaedic Biotechnology Co., Ltd., Taichung, TW |
| Decision | Substantially Equivalent, Sep 15, 2026 |
| Received | Dec 29, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K254214
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.