LHQ · Class I · 21 CFR 884.2980

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

Leading manufacturers include Usa Therm, Inc., First Sense Medical, LLC and Intouch Technologies, Inc., D.B.A. Intouch Health.

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 Feb 11, 2003
MARK I THERMAL IMAGER
K023925
Ix-Dr, Inc.
Radiology · 78d
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

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 →