510(k) K221552 ยท QFM Radiological Computer-Assisted Prioritization Software For Lesions
EFAI ChestSuite XR Pneumothorax Assessment System
| Applicant | Ever Fortune.Ai, Co., Ltd., Taichung City, TW |
| Decision | Substantially Equivalent, Nov 8, 2022 |
| Received | May 31, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K221552
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.