RAYSCAN a-Expert3D

FDA 510(k) K232287 · Ray Co., Ltd.

Substantially Equivalent

510(k) numberK232287

Submission

Device name
RAYSCAN a-Expert3D
Applicant
Ray Co., Ltd.
Yongin-Si, KR
Received
August 1, 2023
Decision date
August 31, 2023
Decision
Substantially Equivalent (SESE)
Type
Special 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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More from Fussen Technology Co., Ltd.

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K233625Raydent SWPNN · Traditional 05/16/2024SE
K232325RAYSCAN a-ExpertMUH · Traditional 04/18/2024SE
K230753RCT800OAS · Special 04/11/2023SE
K213226RCT700OAS · Traditional 11/29/2021SE
K211105Ear-Friendly MaskFXX · Traditional 05/17/2021SE
K192737RCT800OAS · Traditional 10/22/2019SE

Questions and answers

When was RAYSCAN a-Expert3D cleared by the FDA?

RAYSCAN a-Expert3D (K232287) received a 510(k) decision of Substantially Equivalent on August 31, 2023, 30 days after the submission was received.

What is the product code of K232287?

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