Cleared Traditional

Digital Radiographic Imaging Acquisition Software - DR (RiasDR) (K251038) - FDA 510(k) Clearance

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K251038 · Shen Zhen Cambridge-Hit Co., Ltd. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2025
Decision
125d
Days
Class 2
Risk

K251038 is an FDA 510(k) clearance for the Digital Radiographic Imaging Acquisition Software - DR (RiasDR). Classified as System, Image Processing, Radiological within the LLZ classification (a category encompassing advanced image processing and PACS-adjacent software), Class II - Special Controls.

Submitted by Shen Zhen Cambridge-Hit Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on August 6, 2025 after a review of 125 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2050 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Incremental AI imaging tool. Moderate equivalence dependency. Overall, this clearance reflects a predicate-aligned approval typical of modern AI radiology extensions - not a novel clinical breakthrough, but a validated iteration within an established regulatory category.

View all Shen Zhen Cambridge-Hit Co., Ltd. devices

Submission Details

510(k) Number K251038 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 2025
Decision Date August 06, 2025
Days to Decision 125 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
18d slower than avg
Panel avg: 107d · This submission: 125d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LLZ System, Image Processing, Radiological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2050
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Consultant

Shenzhen Joyantech Consulting Co., Ltd.
Fu Field

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - LLZ System, Image Processing, Radiological

All 797
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K251038.
Neurovascular Insight V1.0
K243680 · Olea Medical S.A.S. · Aug 2025
RW-1
K232456 · Mediott, Inc. · Aug 2025
Navigo Workstation 2.3 (FPRMC00039)
K250664 · UC-CARE , Ltd. · Aug 2025
iPETcertum (v1.0)
K244016 · Claritas Healthtech Pte, Ltd. · Aug 2025
Neuro Insight V1.0
K243681 · Olea Medical S.A.S. · Jul 2025
IMAGE ONE
K250716 · Infomed Software, S.L. · Jul 2025