ViewPoint 6— 510(k) K241300

Substantially Equivalent

Ge Healthcare GmbH

FDA 510(k) clearance K241300 for ViewPoint 6, Substantially Equivalent on 2024-07-02. Applicant: Ge Healthcare GmbH.

Clearance details

Applicant: Ge Healthcare GmbH
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2024-05-09
Decision date: 2024-07-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: München, DE

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.