FDA 510(k)

Saige-Density (2.5.0)

K 號：K243705 · 2024-12-19

決定日期2024-12-19

產品代碼QIH

諮詢委員會RA

決定相當於

器材摘要

Saige-Density (2.5.0) is the device name listed in this FDA 510(k) record. The listed applicant is DeepHealth, Inc.. It received FDA 510(k) clearance on 2024-12-19 under 510(k) number K243705. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Saige-Density (2.5.0)?

Saige-Density (2.5.0) is a medical device that received FDA 510(k) clearance on 2024-12-19. The listed applicant is DeepHealth, Inc.. The 510(k) number is K243705.

When did Saige-Density (2.5.0) receive FDA 510(k) clearance?

Saige-Density (2.5.0) received FDA 510(k) clearance on 2024-12-19, under 510(k) number K243705.

Who is the listed applicant for Saige-Density (2.5.0)?

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

What is the FDA product code for Saige-Density (2.5.0)?

The FDA product code for Saige-Density (2.5.0) is QIH.

其他以 DeepHealth, Inc. 為申請人之記錄

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。

K253825Saige-Dx K254131BAC K251873Saige-Dx K243703TechLive 醫療設備規範文本翻譯： TechLive 注意事項： 1. 保留公司/產品名稱、FDA、510(k)、PMA、NCT、PMID、識別符和網址。 2. 遵循政策：medical-regulatory-v1。K243688Saige-Dx (3.1.0)K241747Saige-Dx

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相關器械（代碼：QIH）

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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