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FDA 510(k)

RAYSCAN a-Expert3D

K-Number: K190812 · 2019-04-24

ApplicantRay Co., Ltd.
Decision Date2019-04-24
Product CodeOAS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

RAYSCAN a-Expert3D is a medical device manufactured by Ray Co., Ltd.. It received FDA 510(k) clearance on 2019-04-24 under approval number K190812. The device is classified under product code OAS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RAYSCAN a-Expert3D?

RAYSCAN a-Expert3D is a medical device that received FDA 510(k) clearance on 2019-04-24. It is manufactured by Ray Co., Ltd.. The 510(k) number is K190812.

When was RAYSCAN a-Expert3D approved by the FDA?

RAYSCAN a-Expert3D received FDA 510(k) clearance on 2019-04-24, under approval number K190812.

What company makes RAYSCAN a-Expert3D?

RAYSCAN a-Expert3D is manufactured by Ray Co., Ltd..

What is the FDA product code for RAYSCAN a-Expert3D?

The FDA product code for RAYSCAN a-Expert3D is OAS.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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