Cleared Traditional

K904294 - QSI 9500

K904294 is an FDA 510(k) clearance for QSI 9500, manufactured by Quantified Signal Imaging, Inc.. The device is a Class 2 Neurology device with product code OLU cleared through the Traditional 510(k) pathway after a 314-day FDA review.

K904294 · Quantified Signal Imaging, Inc. · Neurology device
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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

FDA 510(k) Submission Details - K904294

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.

OLU Device Classification - Class 2, Special Controls

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.