510(k) K160584 ยท LLZ System, Image Processing, Radiological
Surgical Navigation Advanced Platform (SNAP)
| Applicant | Surgical Theater, LLC, Mayfield Village OH, US |
| Decision | Substantially Equivalent, Jun 28, 2016 |
| Received | Mar 1, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K160584
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 24, 2025 | Surgical Theater Inc Surgical Navigation Advanced Platform (SNAP), software version SNP.3.12.0, imaging processing radiological system Terminated |
LLZ | None listed |
| Oct 24, 2025 | Surgical Theater Inc Surgical Navigation Advanced Platform Patient Engagement (PE SNAP), software version SNP.3.12.0, imaging processing radiological system Terminated |
LLZ | None listed |
| Oct 24, 2025 | Surgical Theater Inc SyncAR Surgical Navigation Advanced Platform Patient Engagement (SyncAR SNAP), software version SNP.1.12.0, imaging processing radiological system Terminated |
LLZ | None listed |
| Oct 24, 2025 | Surgical Theater Inc Endo Surgical Navigation Advanced Platform Patient Engagement (EndoSNAP), software version SNP.1.12.0, imaging processing radiological system Terminated |
LLZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.