Cleared Traditional

3D Accuitomo 150N

K201378 · J. Morita USA, Inc. · Radiology
Feb 2021
Decision
268d
Days
Class 2
Risk

About This 510(k) Submission

K201378 is an FDA 510(k) clearance for the 3D Accuitomo 150N, 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 February 18, 2021, 268 days after receiving the submission on May 26, 2020. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1750.

Submission Details

510(k) Number K201378 FDA.gov
FDA Decision Cleared SESE
Date Received May 26, 2020
Decision Date February 18, 2021
Days to Decision 268 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.