BreView— 510(k) K233714

Substantially Equivalent

GE Medical Systems SCS

FDA 510(k) clearance K233714 for BreView, Substantially Equivalent on 2024-01-25. Applicant: GE Medical Systems SCS.

Clearance details

Applicant: GE Medical Systems SCS
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2023-11-20
Decision date: 2024-01-25
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.