PAX-FLEX3D, PHT-7000— 510(k) K121412

Substantially Equivalent

VATECH Co., Ltd.

FDA 510(k) clearance K121412 for PAX-FLEX3D, PHT-7000, Substantially Equivalent on 2012-06-08. Applicant: VATECH Co., Ltd..

Clearance details

Applicant: VATECH Co., Ltd.
Product code: Code OAS
Advisory panel: Radiology
Date received: 2012-05-11
Decision date: 2012-06-08
Decision: Substantially Equivalent
Clearance type: Special
Location: Houston, TX, US

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