Volcano iFR Harvest Software (Offline)— 510(k) K143122

Substantially Equivalent

Volcano Corporation

FDA 510(k) clearance K143122 for Volcano iFR Harvest Software (Offline), Substantially Equivalent on 2015-02-20. Applicant: Volcano Corporation.

Clearance details

Applicant: Volcano Corporation
Product code: Code IYO
Advisory panel: Radiology
Date received: 2014-10-31
Decision date: 2015-02-20
Decision: Substantially Equivalent
Clearance type: Special
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code IYO

product code IYO

Malfunction: 3,339
Total: 3,339

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.