Cleared Special

Digital Wireless Intraoral X-Ray Sensor

K230998 · Iray Imaging Technology (Haining) Limited · Radiology
Oct 2023
Decision
196d
Days
Class 2
Risk

About This 510(k) Submission

K230998 is an FDA 510(k) clearance for the Digital Wireless Intraoral X-Ray Sensor, a System, X-ray, Extraoral Source, Digital (Class II — Special Controls, product code MUH), submitted by Iray Imaging Technology (Haining) Limited (Haining, CN). The FDA issued a Cleared decision on October 20, 2023, 196 days after receiving the submission on April 7, 2023. This device falls under the Radiology review panel. Regulated under 21 CFR 872.1800.

Submission Details

510(k) Number K230998 FDA.gov
FDA Decision Cleared SESE
Date Received April 07, 2023
Decision Date October 20, 2023
Days to Decision 196 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code MUH — System, X-ray, Extraoral Source, Digital
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.1800

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