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FDA 510(k)

VOLUX, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM

K-Number: K092171 · 2010-04-26

ApplicantGenoray Co., Ltd.
Decision Date2010-04-26
Product CodeMUH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

VOLUX, 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 2010-04-26 under 510(k) number K092171. 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, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM?

VOLUX, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM is a medical device that received FDA 510(k) clearance on 2010-04-26. The listed applicant is Genoray Co., Ltd.. The 510(k) number is K092171.

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

VOLUX, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM received FDA 510(k) clearance on 2010-04-26, under 510(k) number K092171.

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

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

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Related Devices (Code: MUH)

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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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