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FDA 510(k)

DIGITAL X-RAY IMAGING SYSTEM, MODEL PAX-UNI3D

K-Number: K090467 · 2010-01-08

ApplicantVATECH Co., Ltd.
Decision Date2010-01-08
Product CodeOAS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DIGITAL X-RAY IMAGING SYSTEM, MODEL PAX-UNI3D 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 2010-01-08 under 510(k) number K090467. 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 DIGITAL X-RAY IMAGING SYSTEM, MODEL PAX-UNI3D?

DIGITAL X-RAY IMAGING SYSTEM, MODEL PAX-UNI3D is a medical device that received FDA 510(k) clearance on 2010-01-08. The listed applicant is VATECH Co., Ltd.. The 510(k) number is K090467.

When did DIGITAL X-RAY IMAGING SYSTEM, MODEL PAX-UNI3D receive FDA 510(k) clearance?

DIGITAL X-RAY IMAGING SYSTEM, MODEL PAX-UNI3D received FDA 510(k) clearance on 2010-01-08, under 510(k) number K090467.

Who is the listed applicant for DIGITAL X-RAY IMAGING SYSTEM, MODEL PAX-UNI3D?

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 DIGITAL X-RAY IMAGING SYSTEM, MODEL PAX-UNI3D?

The FDA product code for DIGITAL X-RAY IMAGING SYSTEM, MODEL PAX-UNI3D 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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