Star-X, Intraoral X-ray System
K-Number: K190357 · 2019-03-15
ApplicantHdx Will Corp.
Decision Date2019-03-15
Product CodeEHD
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Star-X, Intraoral X-ray System is a medical device manufactured by Hdx Will Corp.. It received FDA 510(k) clearance on 2019-03-15 under approval number K190357. The device is classified under product code EHD. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Star-X, Intraoral X-ray System?
Star-X, Intraoral X-ray System is a medical device that received FDA 510(k) clearance on 2019-03-15. It is manufactured by Hdx Will Corp.. The 510(k) number is K190357.
When was Star-X, Intraoral X-ray System approved by the FDA?
Star-X, Intraoral X-ray System received FDA 510(k) clearance on 2019-03-15, under approval number K190357.
What company makes Star-X, Intraoral X-ray System?
Star-X, Intraoral X-ray System is manufactured by Hdx Will Corp..
What is the FDA product code for Star-X, Intraoral X-ray System?
The FDA product code for Star-X, Intraoral X-ray System is EHD.
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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.