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FDA 510(k)

COMPUTED TOMOGRAPHY X-RAY SYSTEM

K-Number: K102196 · 2011-03-25

ApplicantVATECH Co., Ltd.
Decision Date2011-03-25
Product CodeOAS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

COMPUTED TOMOGRAPHY X-RAY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is VATECH Co., Ltd.. It received FDA 510(k) clearance on 2011-03-25 under 510(k) number K102196. 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 COMPUTED TOMOGRAPHY X-RAY SYSTEM?

COMPUTED TOMOGRAPHY X-RAY SYSTEM is a medical device that received FDA 510(k) clearance on 2011-03-25. The listed applicant is VATECH Co., Ltd.. The 510(k) number is K102196.

When did COMPUTED TOMOGRAPHY X-RAY SYSTEM receive FDA 510(k) clearance?

COMPUTED TOMOGRAPHY X-RAY SYSTEM received FDA 510(k) clearance on 2011-03-25, under 510(k) number K102196.

Who is the listed applicant for COMPUTED TOMOGRAPHY X-RAY SYSTEM?

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

What is the FDA product code for COMPUTED TOMOGRAPHY X-RAY SYSTEM?

The FDA product code for COMPUTED TOMOGRAPHY X-RAY SYSTEM is OAS.

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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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