FDA 510(k)

Dental Computed Tomography X-Ray System, Green X

Número K: K201627 · 2020-10-27

Data da decisão2020-10-27

Código do produtoOAS

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

Dental Computed Tomography X-Ray System, Green X is the device name listed in this FDA 510(k) record. The listed applicant is VATECH Co., Ltd.. It received FDA 510(k) clearance on 2020-10-27 under 510(k) number K201627. 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, Green X?

Dental Computed Tomography X-Ray System, Green X is a medical device that received FDA 510(k) clearance on 2020-10-27. The listed applicant is VATECH Co., Ltd.. The 510(k) number is K201627.

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

Dental Computed Tomography X-Ray System, Green X received FDA 510(k) clearance on 2020-10-27, under 510(k) number K201627.

Who is the listed applicant for Dental Computed Tomography X-Ray System, Green X?

The FDA 510(k) record lists VATECH 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, Green X?

The FDA product code for Dental Computed Tomography X-Ray System, Green X is OAS.

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Outros registros que listam VATECH Co., Ltd. como candidato(a)

K260093Green X 12 VE (PHT-70CHS); Green X VE (PHT-70CHS)K243088Green X 12 SE (PHT-40CHS)K243081Green X 21 (PHT-90CHO)K240040VistaPano S Ceph 2.0 (VistaPano S Ceph); VistaPano S 2.0 (VistaPano S); ProVecta S-Pan Ceph 2.0 (ProVecta S-Pan Ceph); ProVecta S-Pan 2.0 (ProVecta S-Pan)K231796Grreen X 12 (Model: PHT-75CHS)K223058EzRay Air 2 Wall (Model: VEX-S350W)

Ver todos os 18 dispositivos →

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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