System, X-Ray, Extra oral Source, Digital, PaX-i Plus, PaX-i Insight— 510(k) K170731

Name: FDA 510(k) clearance K170731
Creator: U.S. Food and Drug Administration
Published: 2017-04-04

Substantially Equivalent

VATECH Co., Ltd.

FDA 510(k) clearance K170731 for System, X-Ray, Extra oral Source, Digital, PaX-i Plus, PaX-i Insight, Substantially Equivalent on 2017-04-04. Applicant: VATECH Co., Ltd.. Device class: 2.

Clearance details

Applicant: VATECH Co., Ltd.
Product code: Code MUH
Device class: Class 2
Regulation: 21 CFR 872.1800
Advisory panel: Dental
Date received: 2017-03-10
Decision date: 2017-04-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hwaseong-Si, KR

Download summary PDF View on FDA.gov ↗

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