510(k) K100113 ยท MOS Coil, Magnetic Resonance, Specialty
VANGUARD BREAST MRI AUXILIARY TABLE WITH 16 CHANNEL COIL ARRAY FOR GE 3T MRI SYSTEM, MODEL 4000451-51
| Applicant | Sentinelle Medical, Inc., Toronto, Ontario, CA |
| Decision | Substantially Equivalent, Apr 22, 2010 |
| Received | Jan 14, 2010 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K100113
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 6, 2016 | Invivo Corporation Invivo Sentinelle Venguard Breast MRI Auxiliary Table/Tabletop with 8/16 Channel Coil Array for GE 1.5T/3T MRI Systems. Terminated |
MOS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.