PAX-DUO3D PLUS, PCT-5000— 510(k) K121236

Substantially Equivalent

VATECH Co., Ltd.

FDA 510(k) clearance K121236 for PAX-DUO3D PLUS, PCT-5000, Substantially Equivalent on 2012-05-24. 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: 2012-04-24
Decision date: 2012-05-24
Decision: Substantially Equivalent
Clearance type: Special
Location: Houston, TX, US

Download summary PDF View on FDA.gov ↗

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