Cleared Traditional

K073581 - ICI P AND S SERIES IR CAMERAS

K073581 is an FDA 510(k) clearance for ICI P AND S SERIES IR CAMERAS, manufactured by Texas Infrared. The device is a Class 1 Radiology device with product code LHQ cleared through the Traditional 510(k) pathway after a 204-day FDA review.

K073581 · Texas Infrared · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2008
Decision
204d
Days
Class 1
Risk

K073581 is an FDA 510(k) clearance for the ICI P AND S SERIES IR CAMERAS. Classified as System, Telethermographic (adjunctive Use) (product code LHQ), Class I - General Controls.

Submitted by Texas Infrared (Austin, US). The FDA issued a Cleared decision on July 11, 2008 after a review of 204 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 Texas Infrared devices

FDA 510(k) Submission Details - K073581

510(k) Number K073581 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 2007
Decision Date July 11, 2008
Days to Decision 204 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
97d slower than avg
Panel avg: 107d · This submission: 204d
Pathway characteristics
Predicate-based equivalence. Third-party reviewed.

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 11
Devices cleared under the same product code (LHQ) and FDA review panel - the closest regulatory comparables to K073581.
IRIS-XP
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OMNICORDER BIOSCAN SYSTEM
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THERMATREK IRIS-3 INFRARED IMAGING SYSTEM
K982112 · Thermatrek, Inc. · Aug 1998
INFRAMETRICS INFRACAM-MED
K982327 · Inframetrics, Inc. · Aug 1998