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FDA 510(k)

General Radiography X-ray System (Model: GR10X 40K), General Radiography X-ray System (Model: GR10X 50K)

Número K: K220149 · 2022-04-19

RequerenteXera Medical Systems & Technology , Ltd.
Data da decisão2022-04-19
Código do produtoKPR
Comité consultivoRA
DecisãoSubstantially Equivalent

Resumo do dispositivo

General Radiography X-ray System (Model: GR10X 40K), General Radiography X-ray System (Model: GR10X 50K) is the device name listed in this FDA 510(k) record. The listed applicant is Xera Medical Systems & Technology , Ltd.. It received FDA 510(k) clearance on 2022-04-19 under 510(k) number K220149. The device is classified under product code KPR. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the General Radiography X-ray System (Model: GR10X 40K), General Radiography X-ray System (Model: GR10X 50K)?

General Radiography X-ray System (Model: GR10X 40K), General Radiography X-ray System (Model: GR10X 50K) is a medical device that received FDA 510(k) clearance on 2022-04-19. The listed applicant is Xera Medical Systems & Technology , Ltd.. The 510(k) number is K220149.

When did General Radiography X-ray System (Model: GR10X 40K), General Radiography X-ray System (Model: GR10X 50K) receive FDA 510(k) clearance?

General Radiography X-ray System (Model: GR10X 40K), General Radiography X-ray System (Model: GR10X 50K) received FDA 510(k) clearance on 2022-04-19, under 510(k) number K220149.

Who is the listed applicant for General Radiography X-ray System (Model: GR10X 40K), General Radiography X-ray System (Model: GR10X 50K)?

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

What is the FDA product code for General Radiography X-ray System (Model: GR10X 40K), General Radiography X-ray System (Model: GR10X 50K)?

The FDA product code for General Radiography X-ray System (Model: GR10X 40K), General Radiography X-ray System (Model: GR10X 50K) is KPR.

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Dispositivos Relacionados (Código: KPR)

Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.

K260227EXSYS DEXi (EXSYS DEXi-S40S); EXSYS DEXi (EXSYS DEXi-S40P); EXSYS DEXi (EXSYS DEXi-S40T); EXSYS DEXi (EXSYS DEXi-S50HDRTECH CorporationK260488MULTIX Impact; MULTIX Impact CSiemens Medical Solutions USA, Inc.K260481GC85ASamsung Electronics Co., Ltd.K260482DRE DuoJpi Healthcare Co, Ltd.K253446AeroDR TX c02Dk Medical Systems Co., Ltd.K250954DRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray System, Lux HD 35 detector, Lux HD 43 detectorCarestream Health

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