Cleared Traditional

K033967 - TELETHERMOGRAPHIC CAMERA, SERIES A, E, S AND P

K033967 is an FDA 510(k) clearance for TELETHERMOGRAPHIC CAMERA, manufactured by Flir Systems. The device is a Class 1 Radiology device with product code LHQ cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K033967 · Flir Systems · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2004
Decision
78d
Days
Class 1
Risk

K033967 is an FDA 510(k) clearance for the TELETHERMOGRAPHIC CAMERA, SERIES A, E, S AND P. Classified as System, Telethermographic (adjunctive Use) (product code LHQ), Class I - General Controls.

Submitted by Flir Systems (Mccordsville, US). The FDA issued a Cleared decision on March 9, 2004 after a review of 78 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.

FDA 510(k) Submission Details - K033967

510(k) Number K033967 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 2003
Decision Date March 09, 2004
Days to Decision 78 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
29d faster than avg
Panel avg: 107d · This submission: 78d
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 40
Devices cleared under the same product code (LHQ) and FDA review panel - the closest regulatory comparables to K033967.
ICI P AND S SERIES IR CAMERAS
K073581 · Texas Infrared · Jul 2008
MEDHOT MTI 2000 THERMAL IMAGING SYSTEM
K063047 · Medhot Thermal Imaging, Inc. · Oct 2006
EMD THERMOGRAPHY SYSTEM
K050239 · Em Diagnostics, Inc. · Mar 2006
INFRARED SCIENCES BREASTSCAN IR SYSTEM
K032350 · Infrared Sciences Corp. · Feb 2004
TYTRON C-500IR CLINICAL INFRARED IMAGING SYSTEM
K032471 · Titronics Research & Development Co. · Oct 2003
THERMATREK IRIS-IV INFRARED IMAGING SYSTEM
K030165 · Thermatrek · Apr 2003
K033967 · TELETHERMOGRAPHIC CAMERA, SERIES A, E, S AND P
Download PDF FDA Summary Flir Systems