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) Official FDA 510(k) Summary (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.

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
Combination Product No
PCCP Authorized No
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 Consultant

Intertek Testing Services
DANIEL W LEHTONEN

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - LHQ System, Telethermographic (adjunctive Use)

All 40
Devices cleared under the same product code (LHQ) and FDA review panel - the closest regulatory comparables to K073581.
AlfaSight 9000 Thermographic System
K150457 · Alfa Thermodiagnostics, Inc. · Apr 2015
NOTOUCH BREASTSCAN
K113259 · Ue Lifesciences, Inc. · Feb 2012
AG THERMOGRAPHIC CAMERA, MODEL ATIR-M301
K101641 · Ag Digital Technology Corp. · Jun 2011
MEDHOT MTI 2000 THERMAL IMAGING SYSTEM
K063047 · Medhot Thermal Imaging, Inc. · Oct 2006
EMD THERMOGRAPHY SYSTEM
K050239 · Em Diagnostics, Inc. · Mar 2006
TELETHERMOGRAPHIC CAMERA, SERIES A, E, S AND P
K033967 · Flir Systems · Mar 2004
K073581 · ICI P AND S SERIES IR CAMERAS
Download PDF FDA Summary Texas Infrared