6450 超声系统 (MyLabE80)；6450 超声系统 (MyLabE85)
K号: K253288 · 2026-04-06
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器械摘要
6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85) is the device name listed in this FDA 510(k) record. The listed applicant is Esaote, S.p.A.. It received FDA 510(k) clearance on 2026-04-06 under 510(k) number K253288. 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 6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)?
6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85) is a medical device that received FDA 510(k) clearance on 2026-04-06. The listed applicant is Esaote, S.p.A.. The 510(k) number is K253288.
When did 6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85) receive FDA 510(k) clearance?
6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85) received FDA 510(k) clearance on 2026-04-06, under 510(k) number K253288.
Who is the listed applicant for 6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)?
FDA 510(k)记录中列出Esaote, S.p.A.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 6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)?
The FDA product code for 6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85) 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。
列明Esaote, S.p.A.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。
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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