FDA 510(k)

Dental Cone-beam Computed Tomography (FinScan F350)

N.º K: K242805 · 2025-01-09

SolicitanteChangzhou Finno Medical Technology Co., Ltd.

Fecha de decisión2025-01-09

Código de productoOAS

Comité asesorRA

DecisiónSubstantially Equivalent

Resumen del dispositivo

Dental Cone-beam Computed Tomography (FinScan F350) is the device name listed in this FDA 510(k) record. The listed applicant is Changzhou Finno Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-01-09 under 510(k) number K242805. 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 (FinScan F350)?

Dental Cone-beam Computed Tomography (FinScan F350) is a medical device that received FDA 510(k) clearance on 2025-01-09. The listed applicant is Changzhou Finno Medical Technology Co., Ltd.. The 510(k) number is K242805.

When did Dental Cone-beam Computed Tomography (FinScan F350) receive FDA 510(k) clearance?

Dental Cone-beam Computed Tomography (FinScan F350) received FDA 510(k) clearance on 2025-01-09, under 510(k) number K242805.

Who is the listed applicant for Dental Cone-beam Computed Tomography (FinScan F350)?

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

What is the FDA product code for Dental Cone-beam Computed Tomography (FinScan F350)?

The FDA product code for Dental Cone-beam Computed Tomography (FinScan F350) is OAS.

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Fuente oficial

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