FDA 510(k)

Dental Computed Tomography X-ray System

Número K: K251842 · 2025-11-13

Data da decisão2025-11-13

Código do produtoOAS

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

Dental Computed Tomography X-ray System is the device name listed in this FDA 510(k) record. The listed applicant is Fussen Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-11-13 under 510(k) number K251842. The device is classified under product code OAS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Dental Computed Tomography X-ray System?

Dental Computed Tomography X-ray System is a medical device that received FDA 510(k) clearance on 2025-11-13. The listed applicant is Fussen Technology Co., Ltd.. The 510(k) number is K251842.

When did Dental Computed Tomography X-ray System receive FDA 510(k) clearance?

Dental Computed Tomography X-ray System received FDA 510(k) clearance on 2025-11-13, under 510(k) number K251842.

Who is the listed applicant for Dental Computed Tomography X-ray System?

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

What is the FDA product code for Dental Computed Tomography X-ray System?

The FDA product code for Dental Computed Tomography X-ray System is OAS.

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