510(k) K191008 ยท DQK Computer, Diagnostic, Programmable
iLab Polaris Multi-Modality Guidance System
| Applicant | Boston Scientific Corporation, San Jose CA, US |
| Decision | Substantially Equivalent, Jul 2, 2019 |
| Received | Apr 16, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191008
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 18, 2019 | Boston Scientific Corporation iLab Polaris Multi-Modality Guidance System; iLab Ultrasound Imaging System Completed |
DQK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.