System, Telethermographic (Adjunctive Use)

FDA product code LHQ · 40 cleared devices

Class 1 Obstetrics/Gynecology

Regulation: 21 CFR 884.2980
Review panel: RA
Implant: No
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1984-07-28 – 2026-05-20

LHQ 2026-05-20

Derma-2

Applicant Neko Health AB

K number K253911

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LHQ 2023-09-14

ThermPix Thermovisual Camera

Applicant Usa Therm, Inc.

K number K232462

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LHQ 2022-04-12

ThermPix Thermovisual Camera

Applicant Usa Therm, Inc.

K number K213650

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LHQ 2022-03-10

Smile-100 System

Applicant Niramai Health Analytix Private Limited

K number K212965

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LHQ 2021-09-13

IRIS-XP

Applicant Medicore Co., Ltd.

K number K212412

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LHQ 2021-01-06

Thermidas IR System (ThIR-A615)

Applicant Thermidas Americas, Inc.

K number K200999

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LHQ 2019-03-25

InTouch Thermal Camera

Applicant Intouch Technologies, Inc., D.B.A. Intouch Health

K number K181716

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LHQ 2017-12-08

Med-Hot Thermal Imaging Systems

Applicant Med-Hot Thermal Imaging, Inc.

K number K171928

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LHQ 2017-01-09

Sentinel BreastScan II System

Applicant First Sense Medical, LLC

K number K162767

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LHQ 2016-06-01

FirstSense Breast Exam

Applicant First Sense Medical, LLC

K number K160573

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LHQ 2012-02-10

NOTOUCH BREASTSCAN

Applicant Ue Lifesciences, Inc.

K number K113259

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LHQ 2011-06-16

AG THERMOGRAPHIC CAMERA, MODEL ATIR-M301

Applicant Ag Digital Technology Corp.

K number K101641

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LHQ 2008-07-11

ICI P AND S SERIES IR CAMERAS

Applicant Texas Infrared

K number K073581

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LHQ 2006-10-19

MEDHOT MTI 2000 THERMAL IMAGING SYSTEM

Applicant Medhot Thermal Imaging, Inc.

K number K063047

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LHQ 2006-03-16

EMD THERMOGRAPHY SYSTEM

Applicant Em Diagnostics, Inc.

K number K050239

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LHQ 2004-03-09

TELETHERMOGRAPHIC CAMERA, SERIES A, E, S AND P

Applicant Flir Systems

K number K033967

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LHQ 2004-02-20

INFRARED SCIENCES BREASTSCAN IR SYSTEM

Applicant Infrared Sciences Corp.

K number K032350

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LHQ 2003-10-10

TYTRON C-500IR CLINICAL INFRARED IMAGING SYSTEM

Applicant Titronics Research & Development Co.

K number K032471

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LHQ 2003-04-16

THERMATREK IRIS-IV INFRARED IMAGING SYSTEM

Applicant Thermatrek

K number K030165

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LHQ 2003-03-26

MHS 7000

Applicant Micro Health Systems, Inc.

K number K030018

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LHQ 2003-02-11

MARK I THERMAL IMAGER

Applicant Ix-Dr, Inc.

K number K023925

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LHQ 2002-11-14

DOREX SPECTRUM 9000MB THERMOGRAPHY SYSTEM

Applicant Dorex, Inc.

K number K023434

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LHQ 2002-06-07

TELESIS DIGITAL INFRARED THERMAL IMAGE SYSTEM, SPECTRUM 9000MB

Applicant Telesis Technologies, Inc.

K number K020783

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LHQ 2001-09-05

MHS 5000

Applicant Micro Health Systems, Inc.

K number K011981

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LHQ 2001-02-21

MEDITHERM MED2000

Applicant Meditherm, Inc.

K number K003332

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LHQ 2001-02-16

REGUTHERM 952 THERMOGRAPHIC SYSTEM

Applicant Sie-Med, Inc.

K number K003130

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LHQ 1999-12-23

OMNICORDER BIOSCAN SYSTEM

Applicant Omnicorder Technologies, Inc.

K number K990416

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LHQ 1998-08-20

THERMATREK IRIS-3 INFRARED IMAGING SYSTEM

Applicant Thermatrek, Inc.

K number K982112

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LHQ 1998-08-18

INFRAMETRICS INFRACAM-MED

Applicant Inframetrics, Inc.

K number K982327

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LHQ 1997-08-22

CRT2000 THERMOGRAPHIC SYSTEM

Applicant Werner Eidam Medizin-Technologie GmbH

K number K971956

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LHQ 1995-07-06

OPGAL INTRAOPERATIVE VASCULAR ANGIOGRAPHY SYSTEM (IVA-2000)

Applicant Opgal Optronic Industries

K number K951806

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LHQ 1990-07-13

BSI MODEL TIP

Applicant Bales Scientific, Inc.

K number K897191

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LHQ 1990-05-07

THERMO-5000

Applicant Medtronix Ltd., Inc.

K number K895358

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LHQ 1987-04-03

PM-100 THERMOGRAPH MARK 1026

Applicant Clearwater Computer Center, Inc.

K number K863818

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LHQ 1986-07-18

MODEL 450 INFRARED IMAGING SYSTEM

Applicant Mitek , Inc.

K number K861534

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LHQ 1985-03-22

GST SYSTEM THERMOGRAPHIC APPLICATION

Applicant Gst Laboratories of Ca, Inc.

K number K842878

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LHQ 1985-02-27

BSI MODEL MCT 7000-THERMAL IMAGING SYSTEM

Applicant Bales Scientific, Inc.

K number K850534

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LHQ 1985-02-27

INFRAVIEW/INFRASION-TELETHERMOGRAPHIC SYSTEM

Applicant Image Systems, Inc.

K number K844771

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LHQ 1985-02-11

PROBEYE THERMAL VIDEO SYSTEMS

Applicant Hughes Aircraft Co.

K number K843549

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LHQ 1984-07-28

INFRA-EYE 160

Applicant Fujitsu , Ltd.

K number K841271

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