510(k) K200621 ยท QIH Automated Radiological Image Processing Software
Caption Interpretation Automated Ejection Fraction Software
| Applicant | Caption Health, Brisbane CA, US |
| Decision | Substantially Equivalent, Jul 22, 2020 |
| Received | Mar 9, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K200621
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 19, 2021 | Caption Health Version: 1.2.0 (1.2.0+85ela410) Caption Health, Caption AI, Ultrasound Imaging System Application Software (GMDN: 40873), UDI: (01)00860003586303(10)1.2.0) Terminated |
QIH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.