510(k) K192348 ยท LLZ System, Image Processing, Radiological
SICAT Implant V2.0
| Applicant | Sicat GmbH & Co. KG, Bonn, DE |
| Decision | Substantially Equivalent, Dec 4, 2019 |
| Received | Aug 29, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K192348
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 15, 2020 | SICAT GMBH & CO. KG SICAT IMPLANT V2.0 Terminated |
LLZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.