510(k) K234042 ยท QIH Automated Radiological Image Processing Software
EFAI Bonesuite XR Bone Age Pro Assessment System (BAP-XR-100)
| Applicant | Ever Fortune.Ai, Co., Ltd., Taichung City, TW |
| Decision | Substantially Equivalent, Jun 7, 2024 |
| Received | Dec 21, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K234042
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.