510(k) K173037 ยท GEH Unit, Cryosurgical, Accessories
Visual-ICE MRI Cryoblation Console, Visual-ICE MRI Junction Box Assembly, Visual-ICE MRI Mobile Connection Panel
| Applicant | Galil Medical, Inc., Arden Hills MN, US |
| Decision | Substantially Equivalent, Nov 21, 2017 |
| Received | Sep 28, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K173037
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 22, 2020 | Boston Scientific Corporation Visual-ICE MRI Cryoablation System Mobile Connection Panel (Visual-ICE MRI MCP) - Product Usage: The system is computer-controlled with a touch screen user interface that allows the user to control an Terminated |
GEH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.