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FDA 510(k)

Digital Intraoral X-ray Imaging System

K-Number: K212279 · 2021-10-07

ApplicantIray Technology Taicang , Ltd.
Decision Date2021-10-07
Product CodeMUH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Digital Intraoral X-ray Imaging System is the device name listed in this FDA 510(k) record. The listed applicant is Iray Technology Taicang , Ltd.. It received FDA 510(k) clearance on 2021-10-07 under 510(k) number K212279. 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 Digital Intraoral X-ray Imaging System?

Digital Intraoral X-ray Imaging System is a medical device that received FDA 510(k) clearance on 2021-10-07. The listed applicant is Iray Technology Taicang , Ltd.. The 510(k) number is K212279.

When did Digital Intraoral X-ray Imaging System receive FDA 510(k) clearance?

Digital Intraoral X-ray Imaging System received FDA 510(k) clearance on 2021-10-07, under 510(k) number K212279.

Who is the listed applicant for Digital Intraoral X-ray Imaging System?

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

What is the FDA product code for Digital Intraoral X-ray Imaging System?

The FDA product code for Digital Intraoral X-ray Imaging System is 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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