HESTIA— 510(k) K243420

Substantially Equivalent

Genoray Co., Ltd.

FDA 510(k) clearance K243420 for HESTIA, Substantially Equivalent on 2025-07-17. Applicant: Genoray Co., Ltd..

Clearance details

Applicant: Genoray Co., Ltd.
Product code: Code MUE
Advisory panel: Radiology
Date received: 2024-11-04
Decision date: 2025-07-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seongnam-Si, KR

Download summary PDF View on FDA.gov ↗

Adverse events under product code MUE

product code MUE

Death: 5
Other: 1
Total: 6

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.