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FDA 510(k)

數位X光影像採集軟體 - DR (RiasDR)

K 號：K251038 · 2025-08-06

申請人Shen Zhen Cambridge-Hit Co., Ltd.
決定日期2025-08-06
產品代碼LLZ
諮詢委員會RA
決定相當於

器材摘要

Digital Radiographic Imaging Acquisition Software - DR (RiasDR) is the device name listed in this FDA 510(k) record. The listed applicant is Shen Zhen Cambridge-Hit Co., Ltd.. It received FDA 510(k) clearance on 2025-08-06 under 510(k) number K251038. 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 Digital Radiographic Imaging Acquisition Software - DR (RiasDR)?

Digital Radiographic Imaging Acquisition Software - DR (RiasDR) is a medical device that received FDA 510(k) clearance on 2025-08-06. The listed applicant is Shen Zhen Cambridge-Hit Co., Ltd.. The 510(k) number is K251038.

When did Digital Radiographic Imaging Acquisition Software - DR (RiasDR) receive FDA 510(k) clearance?

Digital Radiographic Imaging Acquisition Software - DR (RiasDR) received FDA 510(k) clearance on 2025-08-06, under 510(k) number K251038.

Who is the listed applicant for Digital Radiographic Imaging Acquisition Software - DR (RiasDR)?

The FDA 510(k) record lists Shen Zhen Cambridge-Hit Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Digital Radiographic Imaging Acquisition Software - DR (RiasDR)?

The FDA product code for Digital Radiographic Imaging Acquisition Software - DR (RiasDR) is LLZ.

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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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