胎儿超声扫描仪（v1.1）
K号: K251071 · 2025-05-02
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器械摘要
Fetal EchoScan (v1.1) is the device name listed in this FDA 510(k) record. The listed applicant is Brightheart. It received FDA 510(k) clearance on 2025-05-02 under 510(k) number K251071. The device is classified under product code POK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Fetal EchoScan (v1.1)?
Fetal EchoScan (v1.1) is a medical device that received FDA 510(k) clearance on 2025-05-02. The listed applicant is Brightheart. The 510(k) number is K251071.
When did Fetal EchoScan (v1.1) receive FDA 510(k) clearance?
Fetal EchoScan (v1.1) received FDA 510(k) clearance on 2025-05-02, under 510(k) number K251071.
Who is the listed applicant for Fetal EchoScan (v1.1)?
The FDA 510(k) record lists Brightheart as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Fetal EchoScan (v1.1)?
The FDA product code for Fetal EchoScan (v1.1) is POK.
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Brightheart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：POK）
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。
K253884Koios DS（3.8）Koios Medical, Inc.K261519Sonio SuspectSonioK254161自动主动脉瓣狭窄软件（AutoAS）GE Medical Systems Ultrasound & Primary Care Diagnostics, LLCK251769RevealAI-LungPrecision Medical Ventures, Inc. Dba RevealdxK252294胎儿超声扫描仪（v1.2）BrightheartK250221StrokeSENS ASPECTS软件应用Circle Cardiovascular Imaging, Inc.
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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