FDA 510(k) Applications for Medical Device Product Code: LHQ (System, Telethermographic (Adjunctive Use))

FDA 510(k) Applications for Medical Device Product Code "LHQ"
(System, Telethermographic (Adjunctive Use))

FDA 510(k) Number	Applicant	Device Name	Decision Date
K101641	AG DIGITAL TECHNOLOGY CORP.	AG THERMOGRAPHIC CAMERA, MODEL ATIR-M301	06/16/2011
K150457	ALFA THERMODIAGNOSTICS, INC.	AlfaSight 9000 Thermographic System	04/10/2015
K023434	DOREX, INC.	DOREX SPECTRUM 9000MB THERMOGRAPHY SYSTEM	11/14/2002
K050239	EM DIAGNOSTICS, INC.	EMD THERMOGRAPHY SYSTEM	03/16/2006
K160573	First Sense Medical, LLC	FirstSense Breast Exam	06/01/2016
K162767	First Sense Medical, LLC	Sentinel BreastScan II System	01/09/2017
K033967	FLIR SYSTEMS	TELETHERMOGRAPHIC CAMERA, SERIES A, E, S AND P	03/09/2004
K982327	INFRAMETRICS, INC.	INFRAMETRICS INFRACAM-MED	08/18/1998
K032350	INFRARED SCIENCES CORP.	INFRARED SCIENCES BREASTSCAN IR SYSTEM	02/20/2004
K181716	InTouch Technologies, Inc., d.b.a. InTouch Health	InTouch Thermal Camera	03/25/2019
K023925	IX-DR, INC.	MARK I THERMAL IMAGER	02/11/2003
K171928	Med-Hot Thermal Imaging Inc.	Med-Hot Thermal Imaging Systems	12/08/2017
K063047	MEDHOT THERMAL IMAGING, INC.	MEDHOT MTI 2000 THERMAL IMAGING SYSTEM	10/19/2006
K212412	Medicore Co., Ltd.	IRIS-XP	09/13/2021
K003332	MEDITHERM, INC.	MEDITHERM MED2000	02/21/2001
K011981	MICRO HEALTH SYSTEMS INC.	MHS 5000	09/05/2001
K030018	MICRO HEALTH SYSTEMS INC.	MHS 7000	03/26/2003
K212965	Niramai Health Analytix Private Limited	Smile-100 System	03/10/2022
K990416	OMNICORDER TECHNOLOGIES, INC.	OMNICORDER BIOSCAN SYSTEM	12/23/1999
K003130	SIE-MED, INC.	REGUTHERM 952 THERMOGRAPHIC SYSTEM	02/16/2001
K020783	TELESIS TECHNOLOGIES INC.	TELESIS DIGITAL INFRARED THERMAL IMAGE SYSTEM, SPECTRUM 9000MB	06/07/2002
K073581	TEXAS INFRARED	ICI P AND S SERIES IR CAMERAS	07/11/2008
K030165	THERMATREK	THERMATREK IRIS-IV INFRARED IMAGING SYSTEM	04/16/2003
K982112	THERMATREK, INC.	THERMATREK IRIS-3 INFRARED IMAGING SYSTEM	08/20/1998
K200999	Thermidas Americas, Inc.	Thermidas IR System (ThIR-A615)	01/06/2021
K032471	TITRONICS RESEARCH & DEVELOPMENT CO.	TYTRON C-500IR CLINICAL INFRARED IMAGING SYSTEM	10/10/2003
K113259	UE LIFESCIENCES, INC.	NOTOUCH BREASTSCAN	02/10/2012
K213650	USA Therm, Inc.	ThermPix Thermovisual Camera	04/12/2022
K232462	USA Therm, Inc.	ThermPix Thermovisual Camera	09/14/2023
K971956	WERNER EIDAM MEDIZIN-TECHNOLOGIE GMBH	CRT2000 THERMOGRAPHIC SYSTEM	08/22/1997

FDA 510(k) Applications for Medical Device Product Code "LHQ" (System, Telethermographic (Adjunctive Use))

FDA 510(k) Applications for Medical Device Product Code "LHQ"
(System, Telethermographic (Adjunctive Use))