Cleared Traditional

ScanX Touch/ScanX Duo Touch

K191623 · Air Techniques, Inc. · Radiology
Aug 2019
Decision
64d
Days
Class 2
Risk

About This 510(k) Submission

K191623 is an FDA 510(k) clearance for the ScanX Touch/ScanX Duo Touch, a System, X-ray, Extraoral Source, Digital (Class II — Special Controls, product code MUH), submitted by Air Techniques, Inc. (Melville, US). The FDA issued a Cleared decision on August 21, 2019, 64 days after receiving the submission on June 18, 2019. This device falls under the Radiology review panel. Regulated under 21 CFR 872.1800.

Submission Details

510(k) Number K191623 FDA.gov
FDA Decision Cleared SESE
Date Received June 18, 2019
Decision Date August 21, 2019
Days to Decision 64 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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