Dental Computed Tomography X-Ray System, Green X— 510(k) K201627

Name: FDA 510(k) clearance K201627
Creator: U.S. Food and Drug Administration
Published: 2020-10-27

Substantially Equivalent

VATECH Co., Ltd.

FDA 510(k) clearance K201627 for Dental Computed Tomography X-Ray System, Green X, Substantially Equivalent on 2020-10-27. 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: 2020-06-16
Decision date: 2020-10-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hwaseong-Si, KR

Download summary PDF View on FDA.gov ↗

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