FDA · official record K251438Substantially Equivalent

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

Name: Dental X-Ray Device (Ai Ray Lite, Ai Ray Pro, Master Ray ) — FDA K251438
Creator: Guilin Woodpecker Medical Instrument Co., Ltd.
Keywords: Dental X-Ray Device (Ai Ray Lite, Ai Ray Pro, Master Ray ), Dental X-Ray Device (Ai Ray Lite, Ai Ray Pro, Master Ray ), K251438, EHD, FDA

United StatesEHDGuilin Woodpecker Medical Instrument Co., Ltd.

Verified

Official record identity

FDA application number: K251438
Decision date: September 04, 2025
Published decision: Substantially Equivalent

Classification

Product code: EHD

Published parties

Applicant: Guilin Woodpecker Medical Instrument Co., Ltd.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Special
Received date: 2025-05-09
Review panel: Dental
Current product-code class (harmonized): 2
Current product-code regulation (harmonized): 872.1800

About this record

This record preserves an application published in the FDA 510(k) bulk export, including the DEN entries FDA includes in that export. Historical decisions do not establish current marketing status. Product-code harmonization is separate from the original application; joined establishment identifiers are not assigned to the applicant. The complete official export is checked daily and raw evidence is retained.