Cleared Traditional

Veraview X800

K171012 · J. Morita USA, Inc. · Radiology
Dec 2017
Decision
259d
Days
Class 2
Risk

About This 510(k) Submission

K171012 is an FDA 510(k) clearance for the Veraview X800, a X-ray, Tomography, Computed, Dental (Class II — Special Controls, product code OAS), submitted by J. Morita USA, Inc. (Irvine, US). The FDA issued a Cleared decision on December 19, 2017, 259 days after receiving the submission on April 4, 2017. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1750.

Submission Details

510(k) Number K171012 FDA.gov
FDA Decision Cleared SESE
Date Received April 04, 2017
Decision Date December 19, 2017
Days to Decision 259 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code OAS — X-ray, Tomography, Computed, Dental
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1750
Definition Produce Cross-sectional Diagnostic X-ray Images Of The Intra-oral Tissue And Teeth.