Cleared Traditional

K140828 - NEUROREADER MEDICAL IMAGE PROCESSING SO...

K140828 is an FDA 510(k) clearance for NEUROREADER MEDICAL IMAGE PROCESSING SO..., manufactured by Brainreader Aps. The device is a Class 2 Radiology device with product code LLZ cleared through the Traditional 510(k) pathway after a 309-day FDA review.

K140828 · Brainreader Aps · Radiology device
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Feb 2015
Decision
309d
Days
Class 2
Risk

K140828 is an FDA 510(k) clearance for the NEUROREADER MEDICAL IMAGE PROCESSING SOFTWARE. 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 Brainreader Aps (Egaa, DK). The FDA issued a Cleared decision on February 4, 2015 after a review of 309 days - an unusually long review period, suggesting complex equivalence evaluation.

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-to-high 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.

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FDA 510(k) Submission Details - K140828

510(k) Number K140828 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 2014
Decision Date February 04, 2015
Days to Decision 309 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
202d slower than avg
Panel avg: 107d · This submission: 309d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LLZ Device Classification - Class 2, Special Controls

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.

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