FDA 510(k)

设备名称：BriefCase-分级

K号: K243548 · 2024-12-11

决定日期2024-12-11

产品代码QFM

咨询委员会RA

决定实质等同

器械摘要

BriefCase-Triage is the device name listed in this FDA 510(k) record. The listed applicant is Aidoc Medical , Ltd.. It received FDA 510(k) clearance on 2024-12-11 under 510(k) number K243548. The device is classified under product code QFM. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the BriefCase-Triage?

BriefCase-Triage is a medical device that received FDA 510(k) clearance on 2024-12-11. The listed applicant is Aidoc Medical , Ltd.. The 510(k) number is K243548.

When did BriefCase-Triage receive FDA 510(k) clearance?

BriefCase-Triage received FDA 510(k) clearance on 2024-12-11, under 510(k) number K243548.

Who is the listed applicant for BriefCase-Triage?

The FDA 510(k) record lists Aidoc Medical , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BriefCase-Triage?

The FDA product code for BriefCase-Triage is QFM.

列明Aidoc Medical , 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。

K261317设备名称：BriefCase-分级 K253578设备名称：BriefCase-Triage：CARE多分级CT用于气胸；心包积液；大型主动脉瘤；肩部骨折或脱位装置 K251195设备名称：BriefCase-分级 K252970设备名称：BriefCase-Triage：CARE多分级CT身体 K253265设备名称：BriefCase-分级 K251406设备名称：BriefCase-分级

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官方来源

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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。