INNOVA EPVISION 2.0, INNOVA EPVISION 2.0— 510(k) K130069

Substantially Equivalent

GE Healthcare

FDA 510(k) clearance K130069 for INNOVA EPVISION 2.0, INNOVA EPVISION 2.0, Substantially Equivalent on 2013-04-05. Applicant: GE Healthcare.

Clearance details

Applicant: GE Healthcare
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2013-01-11
Decision date: 2013-04-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Buc, FR

Download summary PDF View on FDA.gov ↗

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.