Cleared Traditional

K032350 - INFRARED SCIENCES BREASTSCAN IR SYSTEM

K032350 is an FDA 510(k) clearance for INFRARED SCIENCES BREASTSCAN IR SYSTEM, manufactured by Infrared Sciences Corp.. The device is a Class 1 Radiology device with product code LHQ cleared through the Traditional 510(k) pathway after a 205-day FDA review.

K032350 · Infrared Sciences Corp. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2004
Decision
205d
Days
Class 1
Risk

K032350 is an FDA 510(k) clearance for the INFRARED SCIENCES BREASTSCAN IR SYSTEM. Classified as System, Telethermographic (adjunctive Use) (product code LHQ), Class I - General Controls.

Submitted by Infrared Sciences Corp. (Great Neck, US). The FDA issued a Cleared decision on February 20, 2004 after a review of 205 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 884.2980 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Infrared Sciences Corp. devices

FDA 510(k) Submission Details - K032350

510(k) Number K032350 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 30, 2003
Decision Date February 20, 2004
Days to Decision 205 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
98d slower than avg
Panel avg: 107d · This submission: 205d
Pathway characteristics
Predicate-based equivalence.

LHQ Device Classification - Class 1, General Controls

Product Code LHQ System, Telethermographic (adjunctive Use)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 884.2980
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - LHQ System, Telethermographic (adjunctive Use)

All 13
Devices cleared under the same product code (LHQ) and FDA review panel - the closest regulatory comparables to K032350.
InTouch Thermal Camera
K181716 · Intouch Technologies, Inc., D.B.A. Intouch Health · Mar 2019
Med-Hot Thermal Imaging Systems
K171928 · Med-Hot Thermal Imaging, Inc. · Dec 2017
NOTOUCH BREASTSCAN
K113259 · Ue Lifesciences, Inc. · Feb 2012
OMNICORDER BIOSCAN SYSTEM
K990416 · Omnicorder Technologies, Inc. · Dec 1999
THERMATREK IRIS-3 INFRARED IMAGING SYSTEM
K982112 · Thermatrek, Inc. · Aug 1998
INFRAMETRICS INFRACAM-MED
K982327 · Inframetrics, Inc. · Aug 1998