Atlas FDA

LHQ

41 FDA 510(k) clearances · Product code

98 daysmedian time to decision
265 days90th percentile
41clearances measured

FDA profile

Official device name
System, Telethermographic (Adjunctive Use)
Device class
Class I (low risk)
Regulation
21 CFR 884.2980
Medical specialty
Obstetrics/Gynecology
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RecordFirmDate
Derma-2 (K253911)Neko Health AB2026-05-20
ThermPix Thermovisual Camera (K232462)Usa Therm, Inc.2023-09-14
ThermPix Thermovisual Camera (K213650)Usa Therm, Inc.2022-04-12
Smile-100 System (K212965)Niramai Health Analytix Private Limited2022-03-10
IRIS-XP (K212412)Medicore Co., Ltd.2021-09-13
Thermidas IR System (ThIR-A615) (K200999)Thermidas Americas, Inc.2021-01-06
InTouch Thermal Camera (K181716)Intouch Technologies, Inc., D.B.A. Intouch Health2019-03-25
Med-Hot Thermal Imaging Systems (K171928)Med-Hot Thermal Imaging, Inc.2017-12-08
Sentinel BreastScan II System (K162767)First Sense Medical, LLC2017-01-09
FirstSense Breast Exam (K160573)First Sense Medical, LLC2016-06-01
AlfaSight 9000 Thermographic System (K150457)Alfa Thermodiagnostics, Inc.2015-04-10
NOTOUCH BREASTSCAN (K113259)Ue Lifesciences, Inc.2012-02-10
AG THERMOGRAPHIC CAMERA, MODEL ATIR-M301 (K101641)Ag Digital Technology Corp.2011-06-16
ICI P AND S SERIES IR CAMERAS (K073581)Texas Infrared2008-07-11
MEDHOT MTI 2000 THERMAL IMAGING SYSTEM (K063047)Medhot Thermal Imaging, Inc.2006-10-19
EMD THERMOGRAPHY SYSTEM (K050239)Em Diagnostics, Inc.2006-03-16
TELETHERMOGRAPHIC CAMERA, SERIES A, E, S AND P (K033967)Flir Systems2004-03-09
INFRARED SCIENCES BREASTSCAN IR SYSTEM (K032350)Infrared Sciences Corp.2004-02-20
TYTRON C-500IR CLINICAL INFRARED IMAGING SYSTEM (K032471)Titronics Research & Development Co.2003-10-10
THERMATREK IRIS-IV INFRARED IMAGING SYSTEM (K030165)Thermatrek2003-04-16
MHS 7000 (K030018)Micro Health Systems, Inc.2003-03-26
MARK I THERMAL IMAGER (K023925)Ix-Dr, Inc.2003-02-11
DOREX SPECTRUM 9000MB THERMOGRAPHY SYSTEM (K023434)Dorex, Inc.2002-11-14
TELESIS DIGITAL INFRARED THERMAL IMAGE SYSTEM, SPECTRUM 9000MB (K020783)Telesis Technologies, Inc.2002-06-07
MHS 5000 (K011981)Micro Health Systems, Inc.2001-09-05
MEDITHERM MED2000 (K003332)Meditherm, Inc.2001-02-21
REGUTHERM 952 THERMOGRAPHIC SYSTEM (K003130)Sie-Med, Inc.2001-02-16
OMNICORDER BIOSCAN SYSTEM (K990416)Omnicorder Technologies, Inc.1999-12-23
THERMATREK IRIS-3 INFRARED IMAGING SYSTEM (K982112)Thermatrek, Inc.1998-08-20
INFRAMETRICS INFRACAM-MED (K982327)Inframetrics, Inc.1998-08-18
CRT2000 THERMOGRAPHIC SYSTEM (K971956)Werner Eidam Medizin-Technologie GmbH1997-08-22
OPGAL INTRAOPERATIVE VASCULAR ANGIOGRAPHY SYSTEM (IVA-2000) (K951806)Opgal Optronic Industries1995-07-06
BSI MODEL TIP (K897191)Bales Scientific, Inc.1990-07-13
THERMO-5000 (K895358)Medtronix Ltd., Inc.1990-05-07
PM-100 THERMOGRAPH MARK 1026 (K863818)Clearwater Computer Center, Inc.1987-04-03
MODEL 450 INFRARED IMAGING SYSTEM (K861534)Mitek , Inc.1986-07-18
GST SYSTEM THERMOGRAPHIC APPLICATION (K842878)Gst Laboratories of Ca, Inc.1985-03-22
BSI MODEL MCT 7000-THERMAL IMAGING SYSTEM (K850534)Bales Scientific, Inc.1985-02-27
INFRAVIEW/INFRASION-TELETHERMOGRAPHIC SYSTEM (K844771)Image Systems, Inc.1985-02-27
PROBEYE THERMAL VIDEO SYSTEMS (K843549)Hughes Aircraft Co.1985-02-11
INFRA-EYE 160 (K841271)Fujitsu , Ltd.1984-07-28

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Every clearance here is in the API, with alerts when new ones post.