Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

LHQ — Predicate Candidate Screening

41 FDA 510(k) clearances under this product code; the 50 most recent screened below.

98 daysmedian FDA review time

265 days90th percentile

41clearances measured

K-number	Device	Applicant	Decided	Review days
K253911	Derma-2	Neko Health AB	2026-05-20	163
K232462	ThermPix Thermovisual Camera	Usa Therm, Inc.	2023-09-14	30
K213650	ThermPix Thermovisual Camera	Usa Therm, Inc.	2022-04-12	144
K212965	Smile-100 System	Niramai Health Analytix Private Limited	2022-03-10	175
K212412	IRIS-XP	Medicore Co., Ltd.	2021-09-13	41
K200999	Thermidas IR System (ThIR-A615)	Thermidas Americas, Inc.	2021-01-06	265
K181716	InTouch Thermal Camera	Intouch Technologies, Inc., D.B.A. Intouch Health	2019-03-25	270
K171928	Med-Hot Thermal Imaging Systems	Med-Hot Thermal Imaging, Inc.	2017-12-08	164
K162767	Sentinel BreastScan II System	First Sense Medical, LLC	2017-01-09	101
K160573	FirstSense Breast Exam	First Sense Medical, LLC	2016-06-01	93
K150457	AlfaSight 9000 Thermographic System	Alfa Thermodiagnostics, Inc.	2015-04-10	49
K113259	NOTOUCH BREASTSCAN	Ue Lifesciences, Inc.	2012-02-10	98
K101641	AG THERMOGRAPHIC CAMERA, MODEL ATIR-M301	Ag Digital Technology Corp.	2011-06-16	371
K073581	ICI P AND S SERIES IR CAMERAS	Texas Infrared	2008-07-11	204
K063047	MEDHOT MTI 2000 THERMAL IMAGING SYSTEM	Medhot Thermal Imaging, Inc.	2006-10-19	15
K050239	EMD THERMOGRAPHY SYSTEM	Em Diagnostics, Inc.	2006-03-16	407
K033967	TELETHERMOGRAPHIC CAMERA, SERIES A, E, S AND P	Flir Systems	2004-03-09	78
K032350	INFRARED SCIENCES BREASTSCAN IR SYSTEM	Infrared Sciences Corp.	2004-02-20	205
K032471	TYTRON C-500IR CLINICAL INFRARED IMAGING SYSTEM	Titronics Research & Development Co.	2003-10-10	60
K030165	THERMATREK IRIS-IV INFRARED IMAGING SYSTEM	Thermatrek	2003-04-16	90
K030018	MHS 7000	Micro Health Systems, Inc.	2003-03-26	83
K023925	MARK I THERMAL IMAGER	Ix-Dr, Inc.	2003-02-11	78
K023434	DOREX SPECTRUM 9000MB THERMOGRAPHY SYSTEM	Dorex, Inc.	2002-11-14	30
K020783	TELESIS DIGITAL INFRARED THERMAL IMAGE SYSTEM, SPECTRUM 9000	Telesis Technologies, Inc.	2002-06-07	88
K011981	MHS 5000	Micro Health Systems, Inc.	2001-09-05	72
K003332	MEDITHERM MED2000	Meditherm, Inc.	2001-02-21	120
K003130	REGUTHERM 952 THERMOGRAPHIC SYSTEM	Sie-Med, Inc.	2001-02-16	133
K990416	OMNICORDER BIOSCAN SYSTEM	Omnicorder Technologies, Inc.	1999-12-23	316
K982112	THERMATREK IRIS-3 INFRARED IMAGING SYSTEM	Thermatrek, Inc.	1998-08-20	65
K982327	INFRAMETRICS INFRACAM-MED	Inframetrics, Inc.	1998-08-18	47
K971956	CRT2000 THERMOGRAPHIC SYSTEM	Werner Eidam Medizin-Technologie GmbH	1997-08-22	87
K951806	OPGAL INTRAOPERATIVE VASCULAR ANGIOGRAPHY SYSTEM (IVA-2000)	Opgal Optronic Industries	1995-07-06	78
K897191	BSI MODEL TIP	Bales Scientific, Inc.	1990-07-13	197
K895358	THERMO-5000	Medtronix Ltd., Inc.	1990-05-07	252
K863818	PM-100 THERMOGRAPH MARK 1026	Clearwater Computer Center, Inc.	1987-04-03	185
K861534	MODEL 450 INFRARED IMAGING SYSTEM	Mitek , Inc.	1986-07-18	85
K842878	GST SYSTEM THERMOGRAPHIC APPLICATION	Gst Laboratories of Ca, Inc.	1985-03-22	242
K850534	BSI MODEL MCT 7000-THERMAL IMAGING SYSTEM	Bales Scientific, Inc.	1985-02-27	16
K844771	INFRAVIEW/INFRASION-TELETHERMOGRAPHIC SYSTEM	Image Systems, Inc.	1985-02-27	82
K843549	PROBEYE THERMAL VIDEO SYSTEMS	Hughes Aircraft Co.	1985-02-11	154
K841271	INFRA-EYE 160	Fujitsu , Ltd.	1984-07-28	123

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda