510(k) K201465 ยท LLZ System, Image Processing, Radiological
SuRgical Planner (SRP) BrainStorm
| Applicant | Surgical Theater, Inc., Mayfield Village OH, US |
| Decision | Substantially Equivalent, Jul 17, 2020 |
| Received | Jun 2, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K201465
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 24, 2025 | Surgical Theater Inc Surgical Planner, BrainSTORM, software version BST.9.3.0, orthopedic augmented reality Terminated |
LLZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.