510(k) K193271 ยท QFM Radiological Computer-Assisted Prioritization Software For Lesions
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| Applicant | Shanghai United Imaging Intelligence Co., Ltd., Shanghai, CN |
| Decision | Substantially Equivalent, Jan 15, 2021 |
| Received | Nov 26, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K193271
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.