FDA 510(k)

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

N.º K: K251438 · 2025-09-04

SolicitanteGuilin Woodpecker Medical Instrument Co., Ltd.

Fecha de decisión2025-09-04

Código de productoEHD

Comité asesorDE

DecisiónSubstantially Equivalent

Resumen del dispositivo

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

Preguntas frecuentes

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. The listed applicant is Guilin Woodpecker Medical Instrument Co., Ltd.. The 510(k) number is K251438.

When did Dental X-Ray Device (Ai Ray Lite, Ai Ray Pro, Master Ray ) receive FDA 510(k) clearance?

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

Who is the listed applicant for Dental X-Ray Device (Ai Ray Lite, Ai Ray Pro, Master Ray )?

The FDA 510(k) record lists Guilin Woodpecker Medical Instrument Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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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Otros registros que enlistan a Guilin Woodpecker Medical Instrument Co., Ltd. como solicitante

K222569Dispositivo de Rayos X Dental Ai Ray K211358Implanter incl. Accessories K221548Dental Air Polishing Handpiece K210367D-Laser Blue, D-Laser 16 K203706Dental Electric Motor K211531Cordless Prophy System, Model: i-Polish

Ver todos los 11 dispositivos →

Dispositivos relacionados (Código: EHD)

K260795Hand-held Dental X-ray System (HyperLight-M)Changzhou Sifary Medical Technology Co., Ltd.K260367Portable Dental X-ray System Model PDX novaPDX Co., Ltd.K253864NOMAD Pro 3Dental Imaging Technologies Corporation K252110Dental X-RAY Unit (AJX200)Guangzhou Ajax Medical Equipment Co., Ltd.K254018Portable Dental X-ray Device (GT-1)Guilin Refine Medical Instrument Co., Ltd.K252909Diagnostic X-Ray Equipment Model POCT22Ningbo Runyes Medical Instrument Co., Ltd.

Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.