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FDA 510(k)

RAYSCAN A-EXPERT 3D

K-Number: K131695 · 2013-11-01

ApplicantRay Co., Ltd.
Decision Date2013-11-01
Product CodeOAS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

RAYSCAN A-EXPERT 3D 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 2013-11-01 under 510(k) number K131695. 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-EXPERT 3D?

RAYSCAN A-EXPERT 3D is a medical device that received FDA 510(k) clearance on 2013-11-01. The listed applicant is Ray Co., Ltd.. The 510(k) number is K131695.

When did RAYSCAN A-EXPERT 3D receive FDA 510(k) clearance?

RAYSCAN A-EXPERT 3D received FDA 510(k) clearance on 2013-11-01, under 510(k) number K131695.

Who is the listed applicant for RAYSCAN A-EXPERT 3D?

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-EXPERT 3D?

The FDA product code for RAYSCAN A-EXPERT 3D is OAS.

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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.

K260462RCT800K251798RCT700K251109SMARTDentK243903RCT600K233625RAYDENT SWK232325RAYSCAN a-Expert

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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.

K261748Dental Cone-beam Computed Tomography (mDX-15P Series)Hefei Meyer Optoelectronic Technology, Inc.K250839Dental X-ray SystemChangzhou Boen Zhongding Medical Technology Co., Ltd.K260662Dental Cone Beam Computed Tomography SystemYofo Medical Technology Co., Ltd.K253935medXion NEXUSmedXion Technologies, Inc.K260462RCT800Ray Co., Ltd.K260093Green X 12 VE (PHT-70CHS); Green X VE (PHT-70CHS)VATECH Co., Ltd.

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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