510(k) K132558 ยท OWB Interventional Fluoroscopic X-Ray System
SYNC-RX SYSTEM
| Applicant | Volcano Corporation, Billerica MA, US |
| Decision | Substantially Equivalent, Dec 12, 2013 |
| Received | Aug 15, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K132558
| 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.