免责声明: 本站汇总 FDA、ClinicalTrials.gov、PubMed、SEC EDGAR 等官方公开数据,仅供一般参考,不构成医疗建议、诊断、治疗建议或投资建议。

FDA 510(k)

AI-Rad Companion(心血管)

K号: K222360 · 2023-04-06

决定日期2023-04-06
产品代码JAK
咨询委员会RA
决定实质等同

器械摘要

AI-Rad Companion (Cardiovascular) is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Medical Solutions U.S.A.. It received FDA 510(k) clearance on 2023-04-06 under 510(k) number K222360. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the AI-Rad Companion (Cardiovascular)?

AI-Rad Companion (Cardiovascular) is a medical device that received FDA 510(k) clearance on 2023-04-06. The listed applicant is Siemens Medical Solutions U.S.A.. The 510(k) number is K222360.

When did AI-Rad Companion (Cardiovascular) receive FDA 510(k) clearance?

AI-Rad Companion (Cardiovascular) received FDA 510(k) clearance on 2023-04-06, under 510(k) number K222360.

Who is the listed applicant for AI-Rad Companion (Cardiovascular)?

The FDA 510(k) record lists Siemens Medical Solutions U.S.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AI-Rad Companion (Cardiovascular)?

The FDA product code for AI-Rad Companion (Cardiovascular) is JAK.

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Siemens Medical Solutions U.S.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:JAK)

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。

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。

↑