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FDA 510(k)

通用X射线摄影系统（型号：GR10X 40K），通用X射线摄影系统（型号：GR10X 50K）

K号: K220149 · 2022-04-19

申请人Xera Medical Systems & Technology , Ltd.
决定日期2022-04-19
产品代码KPR
咨询委员会RA
决定实质等同

器械摘要

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.

常见问题

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.

相关临床试验

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

相关器械（代码：KPR）

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K260227EXSYS DEXi（EXSYS DEXi-S40S）；EXSYS DEXi（EXSYS DEXi-S40P）；EXSYS DEXi（EXSYS DEXi-S40T）；EXSYS DEXi（EXSYS DEXi-S50H）DRTECH 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射线系统，DRX-Compass 移动X射线系统，Lux HD 35探测器，Lux HD 43探测器Carestream Health

官方来源

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