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LHQ — System, Telethermographic (Adjunctive Use) Class I

FDA Device Classification

Classification Details

Product Code
LHQ
Device Class
Class I
Regulation Number
884.2980
Submission Type
Review Panel
RA
Medical Specialty
Obstetrics/Gynecology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K232462usa thermThermPix Thermovisual CameraSeptember 14, 2023
K213650usa thermThermPix Thermovisual CameraApril 12, 2022
K212965niramai health analytix private limitedSmile-100 SystemMarch 10, 2022
K212412medicore coIRIS-XPSeptember 13, 2021
K200999thermidas americasThermidas IR System (ThIR-A615)January 6, 2021
K181716intouch technologies, inc., d.b.a. intouch healthInTouch Thermal CameraMarch 25, 2019
K171928med-hot thermal imagingMed-Hot Thermal Imaging SystemsDecember 8, 2017
K162767first sense medicalSentinel BreastScan II SystemJanuary 9, 2017
K160573first sense medicalFirstSense Breast ExamJune 1, 2016
K150457alfa thermodiagnosticsAlfaSight 9000 Thermographic SystemApril 10, 2015
K113259ue lifesciencesNOTOUCH BREASTSCANFebruary 10, 2012
K101641ag digital technologyAG THERMOGRAPHIC CAMERA, MODEL ATIR-M301June 16, 2011
K073581texas infraredICI P AND S SERIES IR CAMERASJuly 11, 2008
K063047medhot thermal imagingMEDHOT MTI 2000 THERMAL IMAGING SYSTEMOctober 19, 2006
K050239em diagnosticsEMD THERMOGRAPHY SYSTEMMarch 16, 2006
K033967flir systemsTELETHERMOGRAPHIC CAMERA, SERIES A, E, S AND PMarch 9, 2004
K032350infrared sciencesINFRARED SCIENCES BREASTSCAN IR SYSTEMFebruary 20, 2004
K032471titronics research and developmentTYTRON C-500IR CLINICAL INFRARED IMAGING SYSTEMOctober 10, 2003
K030165thermatrekTHERMATREK IRIS-IV INFRARED IMAGING SYSTEMApril 16, 2003
K030018micro health systemsMHS 7000March 26, 2003