FDA 510(k)

TeraRecon Cardiovascular.Calcification.CT

K号: K250288 · 2025-10-23

决定日期2025-10-23

产品代码QIH

咨询委员会RA

决定实质等同

器械摘要

TeraRecon Cardiovascular.Calcification.CT is the device name listed in this FDA 510(k) record. The listed applicant is Terarecon,Inc.. It received FDA 510(k) clearance on 2025-10-23 under 510(k) number K250288. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the TeraRecon Cardiovascular.Calcification.CT?

TeraRecon Cardiovascular.Calcification.CT is a medical device that received FDA 510(k) clearance on 2025-10-23. The listed applicant is Terarecon,Inc.. The 510(k) number is K250288.

When did TeraRecon Cardiovascular.Calcification.CT receive FDA 510(k) clearance?

TeraRecon Cardiovascular.Calcification.CT received FDA 510(k) clearance on 2025-10-23, under 510(k) number K250288.

Who is the listed applicant for TeraRecon Cardiovascular.Calcification.CT?

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

What is the FDA product code for TeraRecon Cardiovascular.Calcification.CT?

The FDA product code for TeraRecon Cardiovascular.Calcification.CT is QIH.

列明Terarecon,Inc.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。

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官方来源

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