Vitrea CT Myocardial Perfusion— 510(k) K150104

Substantially Equivalent

Vital Images, Inc.

FDA 510(k) clearance K150104 for Vitrea CT Myocardial Perfusion, Substantially Equivalent on 2015-04-17. Applicant: Vital Images, Inc..

Clearance details

Applicant: Vital Images, Inc.
Product code: Code JAK
Advisory panel: Radiology
Date received: 2015-01-20
Decision date: 2015-04-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minnetonka, MN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code JAK

product code JAK

Death: 27
Injury: 571
Malfunction: 779
Total: 1,377

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.