SyncVision System— 510(k) K190626

Substantially Equivalent

Volcano Corporation

FDA 510(k) clearance K190626 for SyncVision System, Substantially Equivalent on 2019-04-12. Applicant: Volcano Corporation.

Clearance details

Applicant: Volcano Corporation
Product code: Code OWB
Advisory panel: Radiology
Date received: 2019-03-11
Decision date: 2019-04-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code OWB

product code OWB

Death: 49
Injury: 340
Malfunction: 36,973
Total: 37,362

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.