FFR V2.5— 510(k) K170133

Substantially Equivalent

Philips Volcano

FDA 510(k) clearance K170133 for FFR V2.5, Substantially Equivalent on 2017-05-26. Applicant: Philips Volcano.

Clearance details

Applicant: Philips Volcano
Product code: Code IYO
Advisory panel: Radiology
Date received: 2017-01-17
Decision date: 2017-05-26
Decision: Substantially Equivalent
Clearance type: Traditional
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.