Cleared Traditional

K120949 - INFRASCANNER (FDA 510(k) Clearance)

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

K120949 · Infrascan, Inc. · Neurology device
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Jan 2013
Decision
287d
Days
Class 2
Risk

K120949 is an FDA 510(k) clearance for the INFRASCANNER. Classified as Infrared Hematoma Detector (product code OPT), Class II - Special Controls.

Submitted by Infrascan, Inc. (Philedelphia, US). The FDA issued a Cleared decision on January 11, 2013 after a review of 287 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1935 - 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. Standard predicate reliance. 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 Infrascan, Inc. devices

Submission Details

510(k) Number K120949 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 2012
Decision Date January 11, 2013
Days to Decision 287 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
139d slower than avg
Panel avg: 148d · This submission: 287d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OPT Infrared Hematoma Detector
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1935
Definition To Employ Near-infrared Spectroscopy That Is Intended To Be Used To Evaluate Suspected Brain Hematomas.
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.