WS80A 诊断型超声系统
K号: K153529 · 2016-02-02
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器械摘要
WS80A Diagnostic Ultrasound System is the device name listed in this FDA 510(k) record. The listed applicant is Samsung Medison Co., Ltd.. It received FDA 510(k) clearance on 2016-02-02 under 510(k) number K153529. 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 WS80A Diagnostic Ultrasound System?
WS80A Diagnostic Ultrasound System is a medical device that received FDA 510(k) clearance on 2016-02-02. The listed applicant is Samsung Medison Co., Ltd.. The 510(k) number is K153529.
When did WS80A Diagnostic Ultrasound System receive FDA 510(k) clearance?
WS80A Diagnostic Ultrasound System received FDA 510(k) clearance on 2016-02-02, under 510(k) number K153529.
Who is the listed applicant for WS80A Diagnostic Ultrasound System?
FDA 510(k)记录将三星Medison Co., Ltd.列为申请人。这本身并不能确立该设备的制造商。
What is the FDA product code for WS80A Diagnostic Ultrasound System?
The FDA product code for WS80A Diagnostic Ultrasound System is IYN.
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列明Samsung Medison Co., Ltd.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。
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K261412V8/XV8/XH8/H8/cV8/V8 ONE/XV8 ONE/XH8 ONE/H8 ONE/cV8 ONE 诊断超声系统；V7/XV7/XH7/H7/cV7/V7 ONE/XV7 ONE/H7 ONE/XH7 ONE/cV7 ONE 诊断超声系统；V6/XV6/XH6/H6/cV6/V6 ONE/XV6 ONE/H6 ONE/XH6 ONE/cV6 ONE 诊断超声系统；V5/XV5/XH5/H5/cV5 诊断超声系统；V4/XV4/XH4/H4/cV4 诊断超声系统；K254099EVO Q30 诊断超声系统; EVO Q20 诊断超声系统; EVO Q10 诊断超声系统; EVO XQ30 诊断超声系统; EVO XQ20 诊断超声系统; EVO XQ10 诊断超声系统; EVO QH30 诊断超声系统; EVO QH20 诊断超声系统; EVO QH10 诊断超声系统K252018HERA Z20 诊断型超声系统；HERA Z20e 诊断型超声系统；HERA Z20s 诊断型超声系统；R20 诊断型超声系统；HERA Z30 诊断型超声系统；R30 诊断型超声系统K250999V8诊断超声系统；cV8诊断超声系统；V7诊断超声系统；cV7诊断超声系统；V6诊断超声系统；cV6诊断超声系统；V5诊断超声系统；cV5诊断超声系统；V4诊断超声系统；cV4诊断超声系统K243702V8诊断超声系统；cV8诊断超声系统；V7诊断超声系统；cV7诊断超声系统；V6诊断超声系统；cV6诊断超声系统
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
在 FDA 数据库中查看 →数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。
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