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FDA 510(k)

超声系统 SONIMAGE HS1

K号: K162065 · 2016-10-19

申请人Konica Minolta, Inc.
决定日期2016-10-19
产品代码IYN
咨询委员会RA
决定实质等同

器械摘要

Ultrasound System SONIMAGE HS1 is the device name listed in this FDA 510(k) record. The listed applicant is Konica Minolta, Inc.. It received FDA 510(k) clearance on 2016-10-19 under 510(k) number K162065. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Ultrasound System SONIMAGE HS1?

Ultrasound System SONIMAGE HS1 is a medical device that received FDA 510(k) clearance on 2016-10-19. The listed applicant is Konica Minolta, Inc.. The 510(k) number is K162065.

When did Ultrasound System SONIMAGE HS1 receive FDA 510(k) clearance?

Ultrasound System SONIMAGE HS1 received FDA 510(k) clearance on 2016-10-19, under 510(k) number K162065.

Who is the listed applicant for Ultrasound System SONIMAGE HS1?

The FDA 510(k) record lists Konica Minolta, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Ultrasound System SONIMAGE HS1?

The FDA product code for Ultrasound System SONIMAGE HS1 is IYN.

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

列明Konica Minolta, Inc.为申报人的其他记录

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。

K250665SKR 3000K241319SKR 3000K240281骨抑制软件K230906Konicaminolta DI-X1K223267SKR 3000K220993超声系统 SONIMAGE MX1

查看所有 19 个设备 →

相关器械（代码：IYN）

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。

K263182EVO X30 诊断超声系统；EVO X20 诊断超声系统；EVO X10 诊断超声系统；EVO XP30 诊断超声系统；EVO XP20 诊断超声系统；EVO XP10 诊断超声系统；EVO XC30 诊断超声系统；EVO XC20 诊断超声系统；EVO XC10 诊断超声系统Samsung Medison Co., Ltd.K262548EPIQ Inspira系列诊断超声系统；Affiniti系列诊断超声系统Philips Ultrasound, LLCK261313Vivid 探索者/Vivid 高级/Vivid 焦点GE Medical Systems Ultrasound and Primary Care DiagnosticsK254027数字彩色多普勒超声系统（Marvo 95/Marvo 95 Elite/Marvo 90/Marvo 90 CV/Marvo 90 Pro/Marvo 90 Exp/Marvo 90 Elite/Marvo Expert/Marvo 85/Marvo 85 Pro/Marvo 85 Exp/Marvo 85 Elite/Marvo Senior/Marvo 75 Elite/Marvo 75i/Fenix 95/Fenix 95 Elite/Fenix 90/Fenix 90 Elite/Fenix Expert/Fenix 85/Fenix 85 Elite/Fenix Senior/Fenix 75 Elite/Fenix 75i/Endo 80/Endo 90）Sonoscape Medical Corp.K261668场所：GoGE Medical Systems Ultrasound and Primary care Diagnostics, LLCK262311Alturion系列诊断超声系统Philips Ultrasound, LLC

官方来源

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