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FDA 510(k)

Digital Radiographic Imaging Acquisition Software - DR (RiasDR)

K-Number: K251038 · 2025-08-06

ApplicantShen Zhen Cambridge-Hit Co., Ltd.
Decision Date2025-08-06
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

Related Clinical Trials

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Related Devices (Code: LLZ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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