Cleared Special

K230998 - Digital Wireless Intraoral X-Ray Sensor (FDA 510(k) Clearance)

K230998 · Iray Imaging Technology (Haining) Limited · Radiology device

Oct 2023

Decision

196d

Days

Class 2

Risk

K230998 is an FDA 510(k) clearance for the Digital Wireless Intraoral X-Ray Sensor. This device is classified as 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 FDA review panel. Regulated under 21 CFR 872.1800.

Submission Details

510(k) Number	K230998 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (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