Cleared Traditional

QSI 9500 (K904294) - FDA 510(k) Clearance

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

K904294 · Quantified Signal Imaging, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1991
Decision
314d
Days
Class 2
Risk

K904294 is an FDA 510(k) clearance for the QSI 9500. Classified as Normalizing Quantitative Electroencephalograph Software (product code OLU), Class II - Special Controls.

Submitted by Quantified Signal Imaging, Inc. (Toronto, CA). The FDA issued a Cleared decision on July 30, 1991 after a review of 314 days - an unusually long review period, suggesting complex equivalence evaluation.

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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Quantified Signal Imaging, Inc. devices

Submission Details

510(k) Number K904294 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 1990
Decision Date July 30, 1991
Days to Decision 314 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
166d slower than avg
Panel avg: 148d · This submission: 314d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OLU Normalizing Quantitative Electroencephalograph Software
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1400
Definition Post-hoc Statistical Analysis Of Electroencephalograph Signals With Comparison To A Normative Database 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 - OLU Normalizing Quantitative Electroencephalograph Software

All 11
Devices cleared under the same product code (OLU) and FDA review panel - the closest regulatory comparables to K904294.
NeuroField Analysis Suite
K240420 · Neurofield, Inc. · Sep 2024
iSyncBrain©-C
K222838 · iMediSync, Inc. · Mar 2023
BrainView QEEG Software
K212684 · Medeia, Inc. · Jan 2023
BNA Platform
K202588 · Elminda, Ltd. · Dec 2020
cortiQ PRO
K191432 · G.Tec Medical Engineering GmbH · Jan 2020
qEEG-Pro
K171414 · Brainmaster Technologies, Inc. · Jul 2018