510(k) K151904 ยท OWB Interventional Fluoroscopic X-Ray System
SyncVision System
| Applicant | Volcano Corporation, Billerica MA, US |
| Decision | Substantially Equivalent, Jul 31, 2015 |
| Received | Jul 13, 2015 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K151904
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 19, 2022 | Volcano Corporation SyncVision Systems, Model: 400-0100.10, PN: 30000485688x, with software version 4.2.x Open, Classified |
OWB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.