Cleared Traditional

K241108 - RemedyLogic AI MRI Lumbar Spine Reader (FDA 510(k) Clearance)

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

K241108 · Remedy Logic, Inc. · Radiology device
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Oct 2024
Decision
191d
Days
Class 2
Risk

K241108 is an FDA 510(k) clearance for the RemedyLogic AI MRI Lumbar Spine Reader. 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 Remedy Logic, Inc. (New York, US). The FDA issued a Cleared decision on October 30, 2024 after a review of 191 days - an extended review cycle.

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 Remedy Logic, Inc. devices

Submission Details

510(k) Number K241108 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 22, 2024
Decision Date October 30, 2024
Days to Decision 191 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
84d slower than avg
Panel avg: 107d · This submission: 191d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.

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All 285
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