510(k) K161959 ยท LLZ System, Image Processing, Radiological
ClearView cCAD
| Applicant | Clearview Diagnostics, Inc., Piscataway NJ, US |
| Decision | Substantially Equivalent, Dec 28, 2016 |
| Received | Jul 18, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161959
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 31, 2019 | Koios Medical, Inc. Koios DS Breast . The device is a software application which assists skilled physicians in analyzing breast ultrasound images. Terminated |
LLZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.