510(k) K151613 ยท DQK Computer, Diagnostic, Programmable
iLab Polaris Multi-Modality Guidance System
| Applicant | Boston Scientific Corporation, Maple Grove MN, US |
| Decision | Substantially Equivalent, Oct 6, 2015 |
| Received | Jun 15, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K151613
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.