FDA 510(k)

見模擬報告工具，甲状腺（SMART-T）

K 號：K240697 · 2024-09-09

決定日期2024-09-09

產品代碼QDQ

諮詢委員會RA

決定相當於

器材摘要

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.

常見問題

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.

其他以 See-Mode Technologies Pte, Ltd. 為申請人之記錄

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K201369AVA (增強血管分析)

相關器械（代碼：QDQ）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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官方來源

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