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Panels › Obstetrics/Gynecology › Product code LHQ · Class 1

System, Telethermographic (Adjunctive Use)

Regulation 884.2980

1510(k)s in 12 months (41 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
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Top companies in LHQ

Company510(k)sRecalls
Bales Scientific, Inc.20
First Sense Medical, LLC20
Med-Hot Thermal Imaging, Inc.11
Micro Health Systems, Inc.20
Usa Therm, Inc.20
Thermatrek20
Alfa Thermodiagnostics, Inc.10
Clearwater Computer Center, Inc.10
Ag Digital Technology Corp.10
Dorex, Inc.10
Decided510(k)Device and applicantCode
May 20, 2026K253911Derma-2
Neko Health AB, SE
LHQ
Sep 14, 2023K232462ThermPix Thermovisual Camera
Usa Therm, Inc.
LHQ
Apr 12, 2022K213650ThermPix Thermovisual Camera
Usa Therm, Inc.
LHQ
Mar 10, 2022K212965Smile-100 System
Niramai Health Analytix Private Limited, IN
LHQ
Sep 13, 2021K212412IRIS-XP
Medicore Co., Ltd., KR
LHQ
Jan 6, 2021K200999Thermidas IR System (ThIR-A615)
Thermidas Americas, Inc.
LHQ
Mar 25, 2019K181716InTouch Thermal Camera
Intouch Technologies, Inc., D.B.A. Intouch Health
LHQ
Dec 8, 2017K171928Med-Hot Thermal Imaging Systems
Med-Hot Thermal Imaging, Inc.
LHQ
Jan 9, 2017K162767Sentinel BreastScan II System
First Sense Medical, LLC
LHQ
Jun 1, 2016K160573FirstSense Breast Exam
First Sense Medical, LLC
LHQ
Apr 10, 2015K150457AlfaSight 9000 Thermographic System
Alfa Thermodiagnostics, Inc.
LHQ
Feb 10, 2012K113259NOTOUCH BREASTSCAN
Ue Lifesciences, Inc.
LHQ
Jun 16, 2011K101641AG THERMOGRAPHIC CAMERA, MODEL ATIR-M301
Ag Digital Technology Corp.
LHQ
Jul 11, 2008K073581ICI P AND S SERIES IR CAMERAS
Texas Infrared
LHQ
Oct 19, 2006K063047MEDHOT MTI 2000 THERMAL IMAGING SYSTEM
Medhot Thermal Imaging, Inc.
LHQ
Mar 16, 2006K050239EMD THERMOGRAPHY SYSTEM
Em Diagnostics, Inc.
LHQ
Mar 9, 2004K033967TELETHERMOGRAPHIC CAMERA, SERIES A, E, S AND P
Flir Systems
LHQ
Feb 20, 2004K032350INFRARED SCIENCES BREASTSCAN IR SYSTEM
Infrared Sciences Corp.
LHQ
Oct 10, 2003K032471TYTRON C-500IR CLINICAL INFRARED IMAGING SYSTEM
Titronics Research & Development Co.
LHQ
Apr 16, 2003K030165THERMATREK IRIS-IV INFRARED IMAGING SYSTEM
Thermatrek
LHQ
Mar 26, 2003K030018MHS 7000
Micro Health Systems, Inc.
LHQ
Feb 11, 2003K023925MARK I THERMAL IMAGER
Ix-Dr, Inc.
LHQ
Nov 14, 2002K023434DOREX SPECTRUM 9000MB THERMOGRAPHY SYSTEM
Dorex, Inc.
LHQ
Jun 7, 2002K020783TELESIS DIGITAL INFRARED THERMAL IMAGE SYSTEM, SPECTRUM 9000MB
Telesis Technologies, Inc., TW
LHQ
Sep 5, 2001K011981MHS 5000
Micro Health Systems, Inc.
LHQ
Feb 21, 2001K003332MEDITHERM MED2000
Meditherm, Inc.
LHQ
Feb 16, 2001K003130REGUTHERM 952 THERMOGRAPHIC SYSTEM
Sie-Med, Inc.
LHQ
Dec 23, 1999K990416OMNICORDER BIOSCAN SYSTEM
Omnicorder Technologies, Inc.
LHQ
Aug 20, 1998K982112THERMATREK IRIS-3 INFRARED IMAGING SYSTEM
Thermatrek, Inc.
LHQ
Aug 18, 1998K982327INFRAMETRICS INFRACAM-MED
Inframetrics, Inc.
LHQ
Aug 22, 1997K971956CRT2000 THERMOGRAPHIC SYSTEM
Werner Eidam Medizin-Technologie GmbH
LHQ
Jul 6, 1995K951806OPGAL INTRAOPERATIVE VASCULAR ANGIOGRAPHY SYSTEM (IVA-2000)
Opgal Optronic Industries
LHQ
Jul 13, 1990K897191BSI MODEL TIP
Bales Scientific, Inc.
LHQ
May 7, 1990K895358THERMO-5000
Medtronix Ltd., Inc.
LHQ
Apr 3, 1987K863818PM-100 THERMOGRAPH MARK 1026
Clearwater Computer Center, Inc.
LHQ
Jul 18, 1986K861534MODEL 450 INFRARED IMAGING SYSTEM
Mitek , Inc.
LHQ
Mar 22, 1985K842878GST SYSTEM THERMOGRAPHIC APPLICATION
Gst Laboratories of Ca, Inc.
LHQ
Feb 27, 1985K850534BSI MODEL MCT 7000-THERMAL IMAGING SYSTEM
Bales Scientific, Inc.
LHQ
Feb 27, 1985K844771INFRAVIEW/INFRASION-TELETHERMOGRAPHIC SYSTEM
Image Systems, Inc.
LHQ
Feb 11, 1985K843549PROBEYE THERMAL VIDEO SYSTEMS
Hughes Aircraft Co.
LHQ
Jul 28, 1984K841271INFRA-EYE 160
Fujitsu , Ltd.
LHQ

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