Class Class II

Digital Radiographic Imaging Acquisition Software – DR (RiasDR) (K251038)

K251038 2025-08-06 Traditional
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Description

Digital Radiographic Imaging Acquisition Software - DR (RiasDR) by Shen Zhen Cambridge-Hit Co., Ltd., an FDA 510(k) cleared radiology device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK251038
Clearance Date2025-08-06
Clearance TypeTraditional
Product CodeLLZ
Regulation Number892.2050

Categories

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Predicate lineage for K251038

A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Digital Radiographic Imaging Acquisition Software – DR (RiasDR) (K251038) cites 2 predicate devices and is itself cited by 0 later devices.

Predicate devices cited by this clearance

Devices this clearance was compared against
K numberDeviceApplicantYear
K210316Mars 1417X Wireless Digital Flat Panel DetectorIray Technology Taicang , Ltd.2021
K152172Econsole1DRTECH Corporation2015

Trace the full predicate network for K251038

A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.

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