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FDA 510(k)

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

K-Number: K251438 · 2025-09-04

ApplicantGuilin Woodpecker Medical Instrument Co., Ltd.
Decision Date2025-09-04
Product CodeEHD
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Dental X-Ray Device (Ai Ray Lite, Ai Ray Pro, Master Ray ) is a medical device manufactured by Guilin Woodpecker Medical Instrument Co., Ltd.. It received FDA 510(k) clearance on 2025-09-04 under approval number K251438. The device is classified under product code EHD. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Dental X-Ray Device (Ai Ray Lite, Ai Ray Pro, Master Ray )?

Dental X-Ray Device (Ai Ray Lite, Ai Ray Pro, Master Ray ) is a medical device that received FDA 510(k) clearance on 2025-09-04. It is manufactured by Guilin Woodpecker Medical Instrument Co., Ltd.. The 510(k) number is K251438.

When was Dental X-Ray Device (Ai Ray Lite, Ai Ray Pro, Master Ray ) approved by the FDA?

Dental X-Ray Device (Ai Ray Lite, Ai Ray Pro, Master Ray ) received FDA 510(k) clearance on 2025-09-04, under approval number K251438.

What company makes Dental X-Ray Device (Ai Ray Lite, Ai Ray Pro, Master Ray )?

Dental X-Ray Device (Ai Ray Lite, Ai Ray Pro, Master Ray ) is manufactured by Guilin Woodpecker Medical Instrument Co., Ltd..

What is the FDA product code for Dental X-Ray Device (Ai Ray Lite, Ai Ray Pro, Master Ray )?

The FDA product code for Dental X-Ray Device (Ai Ray Lite, Ai Ray Pro, Master Ray ) is EHD.

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Other Devices by Guilin Woodpecker Medical Instrument Co., Ltd.

K181087Apex Locator, DPEX III K211531Cordless Prophy System, Model: i-Polish K203615Dental Scaler and Air Polisher K212080Imaging Plate Scanner, i-Scan K203320Endo Motor K222569Ai Ray Dental X-Ray Device

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Related Devices (Code: EHD)

K161063EzRay Air (Model VEX-P300)VATECH Co., Ltd. K160458BI IMAGE-X EVOLUTIONRadiotecnologia Industrial S.A. DE C.V. K173319KaVo NOMAD Pro 2 Handheld X-ray SystemAribex K170967Intraskan DC PlusSkanray Technologies Private Limited K163705EzRay Air WVATECH Co., Ltd. K163519RX DCCefla S.C.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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