Product Code: LHQ FDA class 1 21 CFR 884.2980

System, Telethermographic (Adjunctive Use)

Obstetrics/Gynecology

A telethermographic system for adjunctive use is a thermal imaging device that produces infrared temperature maps of the body surface and is intended to be used alongside other diagnostic methods rather than as a standalone screening tool. The device is FDA Class 1, the lowest risk category, requiring only general controls. It carries product code LHQ and is regulated under 21 CFR 884.2980 within the Obstetrics/Gynecology specialty. No special flags apply to this device.

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Basic Information

Product Code: LHQ
Device Class: FDA class 1
Regulation Number: 884.2980
Medical Specialty: Obstetrics/Gynecology
Review Panel: RA
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

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Life Sustain/Support

✗

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 41 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K253911	Derma-2	May 20, 2026	Substantially Equivalent	Neko Health AB
K232462	ThermPix Thermovisual Camera	Sep 14, 2023	Substantially Equivalent	Usa Therm, Inc.
K213650	ThermPix Thermovisual Camera	Apr 12, 2022	Substantially Equivalent	Usa Therm, Inc.
K212965	Smile-100 System	Mar 10, 2022	Substantially Equivalent	Niramai Health Analytix Private Limited
K212412	IRIS-XP	Sep 13, 2021	Substantially Equivalent	Medicore Co., Ltd.
K200999	Thermidas IR System (ThIR-A615)	Jan 06, 2021	Substantially Equivalent	Thermidas Americas, Inc.
K181716	InTouch Thermal Camera	Mar 25, 2019	Substantially Equivalent	Intouch Technologies, Inc., D.B.A. Intouch Health
K171928	Med-Hot Thermal Imaging Systems	Dec 08, 2017	Substantially Equivalent	Med-Hot Thermal Imaging, Inc.
K162767	Sentinel BreastScan II System	Jan 09, 2017	Substantially Equivalent	First Sense Medical, LLC
K160573	FirstSense Breast Exam	Jun 01, 2016	Substantially Equivalent	First Sense Medical, LLC
K150457	AlfaSight 9000 Thermographic System	Apr 10, 2015	Substantially Equivalent	Alfa Thermodiagnostics, Inc.
K113259	NOTOUCH BREASTSCAN	Feb 10, 2012	Substantially Equivalent	Ue Lifesciences, Inc.
K101641	AG THERMOGRAPHIC CAMERA, MODEL ATIR-M301	Jun 16, 2011	Substantially Equivalent	Ag Digital Technology Corp.
K073581	ICI P AND S SERIES IR CAMERAS	Jul 11, 2008	Substantially Equivalent	Texas Infrared
K063047	MEDHOT MTI 2000 THERMAL IMAGING SYSTEM	Oct 19, 2006	Substantially Equivalent	Medhot Thermal Imaging, Inc.
K050239	EMD THERMOGRAPHY SYSTEM	Mar 16, 2006	Substantially Equivalent	Em Diagnostics, Inc.
K033967	TELETHERMOGRAPHIC CAMERA, SERIES A, E, S AND P	Mar 09, 2004	Substantially Equivalent	Flir Systems
K032350	INFRARED SCIENCES BREASTSCAN IR SYSTEM	Feb 20, 2004	Substantially Equivalent	Infrared Sciences Corp.
K032471	TYTRON C-500IR CLINICAL INFRARED IMAGING SYSTEM	Oct 10, 2003	Substantially Equivalent	Titronics Research & Development Co.
K030165	THERMATREK IRIS-IV INFRARED IMAGING SYSTEM	Apr 16, 2003	Substantially Equivalent	Thermatrek
K030018	MHS 7000	Mar 26, 2003	Substantially Equivalent	Micro Health Systems, Inc.
K023925	MARK I THERMAL IMAGER	Feb 11, 2003	Substantially Equivalent	Ix-Dr, Inc.
K023434	DOREX SPECTRUM 9000MB THERMOGRAPHY SYSTEM	Nov 14, 2002	Substantially Equivalent	Dorex, Inc.
K020783	TELESIS DIGITAL INFRARED THERMAL IMAGE SYSTEM, SPECTRUM 9000MB	Jun 07, 2002	Substantially Equivalent	Telesis Technologies, Inc.
K011981	MHS 5000	Sep 05, 2001	Substantially Equivalent	Micro Health Systems, Inc.
K003332	MEDITHERM MED2000	Feb 21, 2001	Substantially Equivalent	Meditherm, Inc.
K003130	REGUTHERM 952 THERMOGRAPHIC SYSTEM	Feb 16, 2001	Substantially Equivalent	Sie-Med, Inc.
K990416	OMNICORDER BIOSCAN SYSTEM	Dec 23, 1999	Substantially Equivalent	Omnicorder Technologies, Inc.
K982112	THERMATREK IRIS-3 INFRARED IMAGING SYSTEM	Aug 20, 1998	Substantially Equivalent	Thermatrek, Inc.
K982327	INFRAMETRICS INFRACAM-MED	Aug 18, 1998	Substantially Equivalent	Inframetrics, Inc.
K971956	CRT2000 THERMOGRAPHIC SYSTEM	Aug 22, 1997	Substantially Equivalent	Werner Eidam Medizin-Technologie GmbH
K951806	OPGAL INTRAOPERATIVE VASCULAR ANGIOGRAPHY SYSTEM (IVA-2000)	Jul 06, 1995	Substantially Equivalent	Opgal Optronic Industries
K897191	BSI MODEL TIP	Jul 13, 1990	Substantially Equivalent	Bales Scientific, Inc.
K895358	THERMO-5000	May 07, 1990	Substantially Equivalent	Medtronix Ltd., Inc.
K863818	PM-100 THERMOGRAPH MARK 1026	Apr 03, 1987	Substantially Equivalent	Clearwater Computer Center, Inc.
K861534	MODEL 450 INFRARED IMAGING SYSTEM	Jul 18, 1986	Substantially Equivalent for Some Indications	Mitek , Inc.
K842878	GST SYSTEM THERMOGRAPHIC APPLICATION	Mar 22, 1985	Substantially Equivalent	Gst Laboratories of Ca, Inc.
K850534	BSI MODEL MCT 7000-THERMAL IMAGING SYSTEM	Feb 27, 1985	Substantially Equivalent	Bales Scientific, Inc.
K844771	INFRAVIEW/INFRASION-TELETHERMOGRAPHIC SYSTEM	Feb 27, 1985	Substantially Equivalent	Image Systems, Inc.
K843549	PROBEYE THERMAL VIDEO SYSTEMS	Feb 11, 1985	Substantially Equivalent	Hughes Aircraft Co.
K841271	INFRA-EYE 160	Jul 28, 1984	Substantially Equivalent	Fujitsu , Ltd.