FDA 510(k)

Dental Cone-beam Computed Tomography

Número K: K232710 · 2024-01-09

RequerenteYian Medical Technology (Haining) Co., Ltd.

Data da decisão2024-01-09

Código do produtoOAS

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

Dental Cone-beam Computed Tomography is the device name listed in this FDA 510(k) record. The listed applicant is Yian Medical Technology (Haining) Co., Ltd.. It received FDA 510(k) clearance on 2024-01-09 under 510(k) number K232710. 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 Cone-beam Computed Tomography?

Dental Cone-beam Computed Tomography is a medical device that received FDA 510(k) clearance on 2024-01-09. The listed applicant is Yian Medical Technology (Haining) Co., Ltd.. The 510(k) number is K232710.

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

Dental Cone-beam Computed Tomography received FDA 510(k) clearance on 2024-01-09, under 510(k) number K232710.

Who is the listed applicant for Dental Cone-beam Computed Tomography?

The FDA 510(k) record lists Yian Medical Technology (Haining) 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?

The FDA product code for Dental Cone-beam Computed Tomography is OAS.

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Outros registros que listam Yian Medical Technology (Haining) Co., Ltd. como candidato(a)

K251642Dental CBCT X-ray System K240855Dental Cone-beam Computed Tomography K220700Heart5R-110 Portable X-Ray Machine, Heart3R-110 Portable X-ray Machine

Dispositivos Relacionados (Código: OAS)

K261748Dental Cone-beam Computed Tomography (mDX-15P Series)Hefei Meyer Optoelectronic Technology, Inc.K250839Dental X-ray SystemChangzhou Boen Zhongding Medical Technology Co., Ltd.K260662Dental Cone Beam Computed Tomography SystemYofo Medical Technology Co., Ltd.K253935medXion NEXUSmedXion Technologies, Inc.K260462RCT800Ray Co., Ltd.K260093Green X 12 VE (PHT-70CHS); Green X VE (PHT-70CHS)VATECH Co., Ltd.

Fonte oficial

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