GT300; GT300-C— 510(k) K250060

Substantially Equivalent

Genoray Co., Ltd.

FDA 510(k) clearance K250060 for GT300; GT300-C, Substantially Equivalent on 2025-10-08. Applicant: Genoray Co., Ltd..

Clearance details

Applicant: Genoray Co., Ltd.
Product code: Code OAS
Advisory panel: Radiology
Date received: 2025-01-10
Decision date: 2025-10-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seongnam-Si, KR

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.