FDA 510(k)

3DICOM MD雲端

K 號：K253784 · 2026-01-08

決定日期2026-01-08

產品代碼LLZ

諮詢委員會RA

決定相當於

器材摘要

3DICOM MD Cloud is the device name listed in this FDA 510(k) record. The listed applicant is Singular Health Pty, Ltd.. It received FDA 510(k) clearance on 2026-01-08 under 510(k) number K253784. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the 3DICOM MD Cloud?

3DICOM MD Cloud is a medical device that received FDA 510(k) clearance on 2026-01-08. The listed applicant is Singular Health Pty, Ltd.. The 510(k) number is K253784.

When did 3DICOM MD Cloud receive FDA 510(k) clearance?

3DICOM MD Cloud received FDA 510(k) clearance on 2026-01-08, under 510(k) number K253784.

Who is the listed applicant for 3DICOM MD Cloud?

The FDA 510(k) record lists Singular Health Pty, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 3DICOM MD Cloud?

The FDA product code for 3DICOM MD Cloud is LLZ.

其他以 Singular Health Pty, Ltd. 為申請人之記錄

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K2224703Dicom MD

相關器械（代碼：LLZ）

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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