510(k) K051679 ยท OBJ Catheter, Ultrasound, Intravascular
ILAB ULTRASOUND IMAGING SYSTEM
| Applicant | Boston Scientific Corp, Fremont CA, US |
| Decision | Substantially Equivalent, Jul 14, 2005 |
| Received | Jun 23, 2005 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K051679
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 1, 2007 | Boston Scientific Target Boston Scientific brand iLab Ultrasound Imaging System, for intravascular use;
Model Number(s): iLab120lNS, iLab2401NS,
Distributed by and Manufactured by:
Boston Scientific Corporation IVUS, Tech Terminated |
DQO | None listed |
| Apr 22, 2006 | Boston Scientific Target iLab Utrasound Imaging System, software controlled Imaging Catheter. Terminated |
DQO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.