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FDA 510(k)

Dental Cone-beam Computed Tomography (mDX-15P Series)

N.º K: K261748 · 2026-07-23

SolicitanteHefei Meyer Optoelectronic Technology, Inc.
Fecha de decisión2026-07-23
Código de productoOAS
Comité asesorRA
DecisiónSubstantially Equivalent

Resumen del dispositivo

Dental Cone-beam Computed Tomography (mDX-15P Series) is the device name listed in this FDA 510(k) record. The listed applicant is Hefei Meyer Optoelectronic Technology, Inc.. It received FDA 510(k) clearance on 2026-07-23 under 510(k) number K261748. The device is classified under product code OAS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Dental Cone-beam Computed Tomography (mDX-15P Series)?

Dental Cone-beam Computed Tomography (mDX-15P Series) is a medical device that received FDA 510(k) clearance on 2026-07-23. The listed applicant is Hefei Meyer Optoelectronic Technology, Inc.. The 510(k) number is K261748.

When did Dental Cone-beam Computed Tomography (mDX-15P Series) receive FDA 510(k) clearance?

Dental Cone-beam Computed Tomography (mDX-15P Series) received FDA 510(k) clearance on 2026-07-23, under 510(k) number K261748.

Who is the listed applicant for Dental Cone-beam Computed Tomography (mDX-15P Series)?

The FDA 510(k) record lists Hefei Meyer Optoelectronic Technology, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Dental Cone-beam Computed Tomography (mDX-15P Series)?

The FDA product code for Dental Cone-beam Computed Tomography (mDX-15P Series) is OAS.

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Dispositivos relacionados (Código: OAS)

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

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Fuente oficial

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

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