PlutoX Digital Intraoral X-Ray Imaging System
K-Number: K210312 · 2021-04-23
ApplicantIray Technology Taicang , Ltd.
Decision Date2021-04-23
Product CodeMUH
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
PlutoX Digital Intraoral X-Ray Imaging System is a medical device manufactured by Iray Technology Taicang , Ltd.. It received FDA 510(k) clearance on 2021-04-23 under approval number K210312. 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 PlutoX Digital Intraoral X-Ray Imaging System?
PlutoX Digital Intraoral X-Ray Imaging System is a medical device that received FDA 510(k) clearance on 2021-04-23. It is manufactured by Iray Technology Taicang , Ltd.. The 510(k) number is K210312.
When was PlutoX Digital Intraoral X-Ray Imaging System approved by the FDA?
PlutoX Digital Intraoral X-Ray Imaging System received FDA 510(k) clearance on 2021-04-23, under approval number K210312.
What company makes PlutoX Digital Intraoral X-Ray Imaging System?
PlutoX Digital Intraoral X-Ray Imaging System is manufactured by Iray Technology Taicang , Ltd..
What is the FDA product code for PlutoX Digital Intraoral X-Ray Imaging System?
The FDA product code for PlutoX 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.