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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 the device name listed in this FDA 510(k) record. The listed applicant is Ray Co., Ltd.. It received FDA 510(k) clearance on 2019-04-24 under 510(k) 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. The listed applicant is Ray Co., Ltd.. The 510(k) number is K190812.

When did RAYSCAN a-Expert3D receive FDA 510(k) clearance?

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

Who is the listed applicant for RAYSCAN a-Expert3D?

The FDA 510(k) record lists Ray Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Ray Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

View all 17 devices →

Related Devices (Code: OAS)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

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