Cleared Traditional

K262134 - NeuroDR

K262134 is an FDA 510(k) clearance for NeuroDR, manufactured by Deep Reasoning Ai, Inc.. The device is a Class 2 Radiology device with product code QIH cleared through the Traditional 510(k) pathway after a 104-day FDA review.

K262134 · Deep Reasoning Ai, Inc. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2026
Decision
104d
Days
Class 2
Risk

K262134 is an FDA 510(k) clearance for the NeuroDR. Classified as Automated Radiological Image Processing Software within the QIH classification (a category dominated by AI-based automated radiology processing systems), Class II - Special Controls.

Submitted by Deep Reasoning Ai, Inc. (Sarasota, US). The FDA issued a Cleared decision on October 7, 2026 after a review of 104 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.

FDA 510(k) Submission Details - K262134

510(k) Number K262134 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 25, 2026
Decision Date October 07, 2026
Days to Decision 104 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
3d faster than avg
Panel avg: 107d · This submission: 104d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

QIH Device Classification - Class 2, Special Controls

Product Code QIH Automated Radiological Image Processing Software
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2050
Definition To Provide Automated Radiological Image Processing And Analysis Tools. Software Implementing Artificial Intelligence Including Nonadaptive Machine Learning Algorithms Trained With Clinical And/or Artificial Data. In These Devices, The Algorithm Training Data Typically Impacts Device Performance. Adaptive Ai Algorithms Are Not Within Scope Of This Product Code.
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

Innolitics, LLC
Cooper Molloy

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.

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K262134 · NeuroDR
Download PDF FDA Summary Deep Reasoning Ai, In…