Cleared Special

Dental X-Ray Device (Ai Ray Lite, Ai Ray Pro, Master Ray )

K251438 · Guilin Woodpecker Medical Instrument Co., Ltd. · Radiology

Sep 2025

Decision

118d

Days

Class 2

Risk

About This 510(k) Submission

K251438 is an FDA 510(k) clearance for the Dental X-Ray Device (Ai Ray Lite, Ai Ray Pro, Master Ray ), a Unit, X-ray, Extraoral With Timer (Class II — Special Controls, product code EHD), submitted by Guilin Woodpecker Medical Instrument Co., Ltd. (Guilin, CN). The FDA issued a Cleared decision on September 4, 2025, 118 days after receiving the submission on May 9, 2025. This device falls under the Radiology review panel. Regulated under 21 CFR 872.1800.

Submission Details

510(k) Number	K251438 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 09, 2025
Decision Date	September 04, 2025
Days to Decision	118 days
Submission Type	Special
Review Panel	Radiology (RA)
Summary	Summary PDF