510(k) K153284 ยท LLZ System, Image Processing, Radiological
Synaptive ImageDrive Pro
| Applicant | Synaptive Medical, Inc., Toronto, CA |
| Decision | Substantially Equivalent, Mar 29, 2016 |
| Received | Nov 12, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K153284
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 26, 2020 | Synaptive Medical Inc Synaptive ImageDrive Clinical Terminated |
LLZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.