3D Accuitomo 150N

FDA 510(k) K201378 · J. Morita USA, Inc.

Substantially Equivalent

510(k) numberK201378

Submission

Device name
3D Accuitomo 150N
Applicant
J. Morita USA, Inc.
Irvine, CA, US
Received
May 26, 2020
Decision date
February 18, 2021
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
OAS – X-Ray, Tomography, Computed, Dental
Device class
Class II (moderate risk)
Regulation
21 CFR 892.1750
Specialty
Radiology

Produce cross-sectional diagnostic x-ray images of the intra-oral tissue and teeth.

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Questions and answers

When was 3D Accuitomo 150N cleared by the FDA?

3D Accuitomo 150N (K201378) received a 510(k) decision of Substantially Equivalent on February 18, 2021, 268 days after the submission was received.

What is the product code of K201378?

The FDA product code is OAS – X-Ray, Tomography, Computed, Dental, a Class II (moderate risk) device regulated under 21 CFR 892.1750.