Cleared Traditional

K863650 - QUANTIMAP III

K863650 is an FDA 510(k) clearance for QUANTIMAP III, manufactured by Quantified Signal Imaging, Inc.. The device is a Class 2 Neurology device with product code OLT cleared through the Traditional 510(k) pathway after a 8-day FDA review.

K863650 · Quantified Signal Imaging, Inc. · Neurology device
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Sep 1986
Decision
8d
Days
Class 2
Risk

K863650 is an FDA 510(k) clearance for the QUANTIMAP III. Classified as Non-normalizing Quantitative Electroencephalograph Software (product code OLT), Class II - Special Controls.

Submitted by Quantified Signal Imaging, Inc. (Toronto, CA). The FDA issued a Cleared decision on September 26, 1986 after a review of 8 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1400 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Quantified Signal Imaging, Inc. devices

FDA 510(k) Submission Details - K863650

510(k) Number K863650 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 18, 1986
Decision Date September 26, 1986
Days to Decision 8 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
140d faster than avg
Panel avg: 148d · This submission: 8d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OLT Device Classification - Class 2, Special Controls

Product Code OLT Non-normalizing Quantitative Electroencephalograph Software
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1400
Definition Analyze Electroencephalograph Data Using Conventional Methodology To Output And Display Standard Electroencephalograph Parameters For Interpretation By A Qualified User.
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 Neurology devices follow this clearance model.

Regulatory Peers - OLT Non-normalizing Quantitative Electroencephalograph Software

All 35
Devices cleared under the same product code (OLT) and FDA review panel - the closest regulatory comparables to K863650.
SPECTRAL EEG MONITOR MODEL A1000
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OTE BIOMEDICA BERG FOURIER ANALYZER
K820653 · Del Mar Avionics · May 1982