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FDA 510(k)

数字放射摄影X射线系统（SONTU100-RAD（E），SONTU300-Mars（E））

K号: K242499 · 2025-01-06

申请人Shenzhen Sontu Medical Imaging Equipment Co., Ltd.
决定日期2025-01-06
产品代码KPR
咨询委员会RA
决定实质等同

器械摘要

Digital Radiography X-ray System (SONTU100-RAD (E) , SONTU300-Mars (E)) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Sontu Medical Imaging Equipment Co., Ltd.. It received FDA 510(k) clearance on 2025-01-06 under 510(k) number K242499. 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 Digital Radiography X-ray System (SONTU100-RAD (E) , SONTU300-Mars (E))?

Digital Radiography X-ray System (SONTU100-RAD (E) , SONTU300-Mars (E)) is a medical device that received FDA 510(k) clearance on 2025-01-06. The listed applicant is Shenzhen Sontu Medical Imaging Equipment Co., Ltd.. The 510(k) number is K242499.

When did Digital Radiography X-ray System (SONTU100-RAD (E) , SONTU300-Mars (E)) receive FDA 510(k) clearance?

Digital Radiography X-ray System (SONTU100-RAD (E) , SONTU300-Mars (E)) received FDA 510(k) clearance on 2025-01-06, under 510(k) number K242499.

Who is the listed applicant for Digital Radiography X-ray System (SONTU100-RAD (E) , SONTU300-Mars (E))?

The FDA 510(k) record lists Shenzhen Sontu Medical Imaging Equipment Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Digital Radiography X-ray System (SONTU100-RAD (E) , SONTU300-Mars (E))?

The FDA product code for Digital Radiography X-ray System (SONTU100-RAD (E) , SONTU300-Mars (E)) 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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