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FDA 510(k)

VOLUX 21C, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM

K-Number: K120263 · 2012-07-10

ApplicantGenoray Co., Ltd.
Decision Date2012-07-10
Product CodeMUH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

VOLUX 21C, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Genoray Co., Ltd.. It received FDA 510(k) clearance on 2012-07-10 under 510(k) number K120263. The device is classified under product code MUH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VOLUX 21C, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM?

VOLUX 21C, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM is a medical device that received FDA 510(k) clearance on 2012-07-10. The listed applicant is Genoray Co., Ltd.. The 510(k) number is K120263.

When did VOLUX 21C, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM receive FDA 510(k) clearance?

VOLUX 21C, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM received FDA 510(k) clearance on 2012-07-10, under 510(k) number K120263.

Who is the listed applicant for VOLUX 21C, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM?

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

What is the FDA product code for VOLUX 21C, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM?

The FDA product code for VOLUX 21C, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM is MUH.

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Related Devices (Code: MUH)

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K251793SOTA Cloud Smart Sensor (1.5)Sota Cloud Corp.K252570EzSensor HD, EzSensor UHDQpix Solutions, Inc.K250687Cocoon Solo (DX-7020s)Dexcowin Global, Inc.K251206Digital X-Ray DentiMax Pro Imaging SystemDentimax, Inc.K240040VistaPano S Ceph 2.0 (VistaPano S Ceph); VistaPano S 2.0 (VistaPano S); ProVecta S-Pan Ceph 2.0 (ProVecta S-Pan Ceph); ProVecta S-Pan 2.0 (ProVecta S-Pan)VATECH Co., Ltd.K242778X Sensor (Model: IOS-A15IF, HDI-15DGF)Qpix Solutions, Inc.

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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