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FDA 510(k)

System, X-Ray, Extra oral Source, Digital, PaX-i Plus, PaX-i Insight

K-Number: K170731 · 2017-04-04

ApplicantVATECH Co., Ltd.
Decision Date2017-04-04
Product CodeMUH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

System, X-Ray, Extra oral Source, Digital, PaX-i Plus, PaX-i Insight 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 2017-04-04 under 510(k) number K170731. 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 System, X-Ray, Extra oral Source, Digital, PaX-i Plus, PaX-i Insight?

System, X-Ray, Extra oral Source, Digital, PaX-i Plus, PaX-i Insight is a medical device that received FDA 510(k) clearance on 2017-04-04. The listed applicant is VATECH Co., Ltd.. The 510(k) number is K170731.

When did System, X-Ray, Extra oral Source, Digital, PaX-i Plus, PaX-i Insight receive FDA 510(k) clearance?

System, X-Ray, Extra oral Source, Digital, PaX-i Plus, PaX-i Insight received FDA 510(k) clearance on 2017-04-04, under 510(k) number K170731.

Who is the listed applicant for System, X-Ray, Extra oral Source, Digital, PaX-i Plus, PaX-i Insight?

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 System, X-Ray, Extra oral Source, Digital, PaX-i Plus, PaX-i Insight?

The FDA product code for System, X-Ray, Extra oral Source, Digital, PaX-i Plus, PaX-i Insight 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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