510(k) K193289— FastStroke, CT Perfusion 4D

Substantially Equivalent

GE Medical Systems SCS

Clearance details

Applicant: GE Medical Systems SCS
Product code: Code JAK
Advisory panel: Radiology
Date received: 2019-11-27
Decision date: 2020-11-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Buc, FR

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.