FDA 510(k)

See-Mode 增强报告工具，甲状腺 (SMART-T)

K号: K240697 · 2024-09-09

决定日期2024-09-09

产品代码QDQ

咨询委员会RA

决定实质等同

器械摘要

See-Mode Augmented Reporting Tool, Thyroid (SMART-T) is the device name listed in this FDA 510(k) record. The listed applicant is See-Mode Technologies Pte, Ltd.. It received FDA 510(k) clearance on 2024-09-09 under 510(k) number K240697. The device is classified under product code QDQ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the See-Mode Augmented Reporting Tool, Thyroid (SMART-T)?

See-Mode Augmented Reporting Tool, Thyroid (SMART-T) is a medical device that received FDA 510(k) clearance on 2024-09-09. The listed applicant is See-Mode Technologies Pte, Ltd.. The 510(k) number is K240697.

When did See-Mode Augmented Reporting Tool, Thyroid (SMART-T) receive FDA 510(k) clearance?

See-Mode Augmented Reporting Tool, Thyroid (SMART-T) received FDA 510(k) clearance on 2024-09-09, under 510(k) number K240697.

Who is the listed applicant for See-Mode Augmented Reporting Tool, Thyroid (SMART-T)?

The FDA 510(k) record lists See-Mode Technologies Pte, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for See-Mode Augmented Reporting Tool, Thyroid (SMART-T)?

The FDA product code for See-Mode Augmented Reporting Tool, Thyroid (SMART-T) is QDQ.

列明See-Mode Technologies Pte, 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。

K201369AVA (增强血管分析)

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