VXvue— 510(k) K251410

Substantially Equivalent

Vieworks Co., Ltd.

FDA 510(k) clearance K251410 for VXvue, Substantially Equivalent on 2025-11-04. Applicant: Vieworks Co., Ltd..

Clearance details

Applicant: Vieworks Co., Ltd.
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2025-05-07
Decision date: 2025-11-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Anyang-Si, KR

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.