PaX-i3D Green Premium (Model: PCT-90LH)— 510(k) K160882

Substantially Equivalent

VATECH Co., Ltd.

FDA 510(k) clearance K160882 for PaX-i3D Green Premium (Model: PCT-90LH), Substantially Equivalent on 2016-10-28. Applicant: VATECH Co., Ltd..

Clearance details

Applicant: VATECH Co., Ltd.
Product code: Code OAS
Advisory panel: Radiology
Date received: 2016-03-31
Decision date: 2016-10-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hwaseong-Si, KR

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