Green X 12 SE (PHT-40CHS)— 510(k) K243088

Substantially Equivalent

VATECH Co., Ltd.

FDA 510(k) clearance K243088 for Green X 12 SE (PHT-40CHS), Substantially Equivalent on 2025-02-21. Applicant: VATECH Co., Ltd..

Clearance details

Applicant: VATECH Co., Ltd.
Product code: Code OAS
Advisory panel: Radiology
Date received: 2024-09-30
Decision date: 2025-02-21
Decision: Substantially Equivalent
Clearance type: Special
Location: Hwaseong-Si, KR

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