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 a medical device manufactured by Iray Technology Taicang , Ltd.. It received FDA 510(k) clearance on 2021-10-07 under approval 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. It is manufactured by Iray Technology Taicang , Ltd.. The 510(k) number is K212279.
When was Digital Intraoral X-ray Imaging System approved by the FDA?
Digital Intraoral X-ray Imaging System received FDA 510(k) clearance on 2021-10-07, under approval number K212279.
What company makes Digital Intraoral X-ray Imaging System?
Digital Intraoral X-ray Imaging System is manufactured by Iray Technology Taicang , Ltd..
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.