510(k) K063493 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
I REVIEW SOFTWARE(ACCESSORY TO) ILAB ULTRASOUND IMAGING SYSTEM) VERSION1.0
| Applicant | Boston Scientific Corp, Fremont CA, US |
| Decision | Substantially Equivalent, Dec 21, 2006 |
| Received | Nov 20, 2006 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K063493
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 17, 2008 | Boston Scientific Corporation iReview" Software (Accessory To) iLab Ultrasound Imaging System,
Model Number: H74900018010, Catalog Number: 1801;
Product is manufactured and distributed by Boston Scientific Corporation, Fremont, Terminated |
IYN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.