Cleared Special

Digital Intraoral X-Ray Sensor

K230811 · Iray Imaging Technology (Haining) Limited · Radiology
Apr 2023
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K230811 is an FDA 510(k) clearance for the Digital 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 April 21, 2023, 28 days after receiving the submission on March 24, 2023. This device falls under the Radiology review panel. Regulated under 21 CFR 872.1800.

Submission Details

510(k) Number K230811 FDA.gov
FDA Decision Cleared SESE
Date Received March 24, 2023
Decision Date April 21, 2023
Days to Decision 28 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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