RAYSCAN a-Expert3D
K-Number: K232287 · 2023-08-31
ApplicantRay Co., Ltd.
Decision Date2023-08-31
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 2023-08-31 under approval number K232287. 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 2023-08-31. It is manufactured by Ray Co., Ltd.. The 510(k) number is K232287.
When was RAYSCAN a-Expert3D approved by the FDA?
RAYSCAN a-Expert3D received FDA 510(k) clearance on 2023-08-31, under approval number K232287.
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.