Cleared Traditional

K982112 - THERMATREK IRIS-3 INFRARED IMAGING SYSTEM (FDA 510(k) Clearance)

Class I Radiology device.

K982112 · Thermatrek, Inc. · Radiology device
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Aug 1998
Decision
65d
Days
Class 1
Risk

K982112 is an FDA 510(k) clearance for the THERMATREK IRIS-3 INFRARED IMAGING SYSTEM. Classified as System, Telethermographic (adjunctive Use) (product code LHQ), Class I - General Controls.

Submitted by Thermatrek, Inc. (Woodbury, US). The FDA issued a Cleared decision on August 20, 1998 after a review of 65 days - a notably fast clearance 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: 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 Thermatrek, Inc. devices

Submission Details

510(k) Number K982112 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 16, 1998
Decision Date August 20, 1998
Days to Decision 65 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
42d faster than avg
Panel avg: 107d · This submission: 65d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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.