LHQ · Class I · 21 CFR 884.2980

FDA Product Code LHQ: System, Telethermographic (adjunctive Use)

Leading manufacturers include First Sense Medical, LLC, Usa Therm, Inc. and Ag Digital Technology Corp..

41
Total
41
Cleared
136d
Avg days
1984
Since
Stable submission activity - 1 submissions in the last 2 years
Review times increasing: avg 163d recently vs 135d historically

FDA 510(k) Cleared System, Telethermographic (adjunctive Use) Devices (Product Code LHQ)

41 devices
1–24 of 41
Cleared May 20, 2026
Derma-2
K253911
Neko Health AB
Radiology · 163d
Cleared Sep 14, 2023
ThermPix Thermovisual Camera
K232462
Usa Therm, Inc.
Radiology · 30d
Cleared Apr 12, 2022
ThermPix Thermovisual Camera
K213650
Usa Therm, Inc.
Radiology · 144d
Cleared Mar 10, 2022
Smile-100 System
K212965
Niramai Health Analytix Private Limited
Radiology · 175d
Cleared Sep 13, 2021
IRIS-XP
K212412
Medicore Co., Ltd.
Radiology · 41d
Cleared Jan 06, 2021
Thermidas IR System (ThIR-A615)
K200999
Thermidas Americas, Inc.
Radiology · 265d
Cleared Mar 25, 2019
InTouch Thermal Camera
K181716
Intouch Technologies, Inc., D.B.A. Intouch Health
Radiology · 270d
Cleared Dec 08, 2017
Med-Hot Thermal Imaging Systems
K171928
Med-Hot Thermal Imaging, Inc.
Radiology · 164d
Cleared Jan 09, 2017
Sentinel BreastScan II System
K162767
First Sense Medical, LLC
Radiology · 101d
Cleared Jun 01, 2016
FirstSense Breast Exam
K160573
First Sense Medical, LLC
Radiology · 93d
Cleared Apr 10, 2015
AlfaSight 9000 Thermographic System
K150457
Alfa Thermodiagnostics, Inc.
Radiology · 49d
Cleared Feb 10, 2012
NOTOUCH BREASTSCAN
K113259
Ue Lifesciences, Inc.
Radiology · 98d
Cleared Jun 16, 2011
AG THERMOGRAPHIC CAMERA, MODEL ATIR-M301
K101641
Ag Digital Technology Corp.
Radiology · 371d
Cleared Jul 11, 2008
ICI P AND S SERIES IR CAMERAS
K073581
Texas Infrared
Radiology · 204d
Cleared Oct 19, 2006
MEDHOT MTI 2000 THERMAL IMAGING SYSTEM
K063047
Medhot Thermal Imaging, Inc.
Radiology · 15d
Cleared Mar 16, 2006
EMD THERMOGRAPHY SYSTEM
K050239
Em Diagnostics, Inc.
Radiology · 407d
Cleared Nov 14, 2002
DOREX SPECTRUM 9000MB THERMOGRAPHY SYSTEM
K023434
Dorex, Inc.
Radiology · 30d
Cleared Jun 07, 2002
TELESIS DIGITAL INFRARED THERMAL IMAGE SYSTEM, SPECTRUM 9000MB
K020783
Telesis Technologies, Inc.
Radiology · 88d
Cleared Sep 05, 2001
MHS 5000
K011981
Micro Health Systems, Inc.
Radiology · 72d
Cleared Feb 21, 2001
MEDITHERM MED2000
K003332
Meditherm, Inc.
Radiology · 120d
Cleared Feb 16, 2001
REGUTHERM 952 THERMOGRAPHIC SYSTEM
K003130
Sie-Med, Inc.
Radiology · 133d
Cleared Dec 23, 1999
OMNICORDER BIOSCAN SYSTEM
K990416
Omnicorder Technologies, Inc.
Radiology · 316d
Cleared Aug 20, 1998
THERMATREK IRIS-3 INFRARED IMAGING SYSTEM
K982112
Thermatrek, Inc.
Radiology · 65d
Cleared Aug 18, 1998
INFRAMETRICS INFRACAM-MED
K982327
Inframetrics, Inc.
Radiology · 47d

About Product Code LHQ - Regulatory Context

510(k) Submission Activity

41 total 510(k) submissions under product code LHQ since 1984, with 41 receiving FDA clearance (average review time: 136 days).

Submission volume has remained relatively stable over the observed period, with 1 submissions in the last 24 months.

FDA 510(k) Review Time - LHQ Product Code

Recent submissions under LHQ have taken an average of 163 days to reach a decision - up from 135 days historically. Manufacturers should account for longer review timelines in current project planning.

LHQ devices are reviewed by the Radiology panel. Browse all Radiology devices →