510(k) K223152— Vision 2, EVARVision, TrackVision 2, HeartVision 2

Substantially Equivalent

GE Medical Systems SCS

Clearance details

Applicant: GE Medical Systems SCS
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2022-10-06
Decision date: 2022-11-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Buc, FR

Adverse events under product code LLZ

product code LLZ

Death: 13
Total: 13

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.