Cleared Traditional

NeuroQuant (K170981) - FDA 510(k) Clearance

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

K170981 · Cortechs Labs, Inc. · Radiology device
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Sep 2017
Decision
157d
Days
Class 2
Risk

K170981 is an FDA 510(k) clearance for the NeuroQuant. 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 Cortechs Labs, Inc. (San Diego, US). The FDA issued a Cleared decision on September 7, 2017 after a review of 157 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 Cortechs Labs, Inc. devices

Submission Details

510(k) Number K170981 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 2017
Decision Date September 07, 2017
Days to Decision 157 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
50d slower than avg
Panel avg: 107d · This submission: 157d
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 Peers - LLZ System, Image Processing, Radiological

All 800
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K170981.
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Elements Image Fusion, Elements Cranial Distortion Correction, Elements Spine Curvature Correction, Elements TRAM
K170816 · Brainlab AG · Sep 2017
syngo Application Software
K170747 · Siemens Medical Solutions USA, Inc. · Jun 2017
Vitrea Software Toshiba Package
K171222 · Toshibamedical Systems Corporation · Jun 2017
Longitudinal Brain Imaging (LoBI) application
K163250 · Philips Medical Systems Nederland B.V. · May 2017