Green X 12 VE (PHT-70CHS); Green X VE (PHT-70CHS)— 510(k) K260093

Name: FDA 510(k) clearance K260093
Creator: U.S. Food and Drug Administration
Published: 2026-03-31

Substantially Equivalent

VATECH Co., Ltd.

FDA 510(k) clearance K260093 for Green X 12 VE (PHT-70CHS); Green X VE (PHT-70CHS), Substantially Equivalent on 2026-03-31. Applicant: VATECH Co., Ltd.. Device class: 2.

Clearance details

Applicant: VATECH Co., Ltd.
Product code: Code OAS
Device class: Class 2
Regulation: 21 CFR 892.1750
Advisory panel: Radiology
Date received: 2026-01-13
Decision date: 2026-03-31
Decision: Substantially Equivalent
Clearance type: Special
Location: Hwaseong-Si, KR

Download summary PDF View on FDA.gov ↗

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