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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 a medical device manufactured by Shen Zhen Cambridge-Hit Co., Ltd.. It received FDA 510(k) clearance on 2025-08-06 under approval 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. It is manufactured by Shen Zhen Cambridge-Hit Co., Ltd.. The 510(k) number is K251038.

When was Digital Radiographic Imaging Acquisition Software - DR (RiasDR) approved by the FDA?

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

What company makes Digital Radiographic Imaging Acquisition Software - DR (RiasDR)?

Digital Radiographic Imaging Acquisition Software - DR (RiasDR) is manufactured by Shen Zhen Cambridge-Hit Co., Ltd..

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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Related PubMed Literature

PMID: 42204020 A Minimal UDI-DICOM Mapping Profile and Validation Artifact for Medical-Device Imaging Workflows. Journal of imaging informatics in medicine (2026) PMID: 42174919 Automating Safety Surveillance for Software-Based Medical Devices: Insights from FDA MAUDE Data. Studies in health technology and informatics (2026) PMID: 41938602 AI-enabled cardiovascular devices: a lifecycle playbook for evidence, change control, and post-market assurance. Frontiers in digital health (2026) PMID: 41883556 A clinician's quick‑start guide to implementing digital health innovations in the NHS - with lessons from a UK-deployed AI stroke imaging decision-support software. Digital health (2026)

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Official Source

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