Dental Computed Tomography X-ray System, PHT-30LFO, PaX-i3D Smart— 510(k) K152106

Substantially Equivalent

VATECH Co., Ltd.

FDA 510(k) clearance K152106 for Dental Computed Tomography X-ray System, PHT-30LFO, PaX-i3D Smart, Substantially Equivalent on 2015-10-23. Applicant: VATECH Co., Ltd..

Clearance details

Applicant: VATECH Co., Ltd.
Product code: Code OAS
Advisory panel: Radiology
Date received: 2015-07-29
Decision date: 2015-10-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hwaseong-Si, KR

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