Cleared Traditional

System, X-Ray, Extra oral Source, Digital, PaX-i Plus, PaX-i Insight

K170731 · VATECH Co., Ltd. · Radiology
Apr 2017
Decision
25d
Days
Class 2
Risk

About This 510(k) Submission

K170731 is an FDA 510(k) clearance for the System, X-Ray, Extra oral Source, Digital, PaX-i Plus, PaX-i Insight, a System, X-ray, Extraoral Source, Digital (Class II — Special Controls, product code MUH), submitted by VATECH Co., Ltd. (Hwaseong-Si, KR). The FDA issued a Cleared decision on April 4, 2017, 25 days after receiving the submission on March 10, 2017. This device falls under the Radiology review panel. Regulated under 21 CFR 872.1800.

Submission Details

510(k) Number K170731 FDA.gov
FDA Decision Cleared SESE
Date Received March 10, 2017
Decision Date April 04, 2017
Days to Decision 25 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code MUH — System, X-ray, Extraoral Source, Digital
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.1800

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