FDA Product Code
FDA Product Code LHQ — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Obstetrics/Gynecology
- 21 CFR Citation
- 884.2980
510(k) Clearances — 41 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K253911 | Derma-2 | Neko Health AB | 2026-05-20 | Traditional | PDF ↗ |
| K232462 | ThermPix Thermovisual Camera | Usa Therm, Inc. | 2023-09-14 | Special | PDF ↗ |
| K213650 | ThermPix Thermovisual Camera | Usa Therm, Inc. | 2022-04-12 | Traditional | PDF ↗ |
| K212965 | Smile-100 System | Niramai Health Analytix Private Limited | 2022-03-10 | Traditional | PDF ↗ |
| K212412 | IRIS-XP | Medicore Co., Ltd. | 2021-09-13 | Traditional | PDF ↗ |
| K200999 | Thermidas IR System (ThIR-A615) | Thermidas Americas, Inc. | 2021-01-06 | Traditional | PDF ↗ |
| K181716 | InTouch Thermal Camera | Intouch Technologies, Inc., D.B.A. Intouch Health | 2019-03-25 | Traditional | PDF ↗ |
| K171928 | Med-Hot Thermal Imaging Systems | Med-Hot Thermal Imaging, Inc. | 2017-12-08 | Traditional | PDF ↗ |
| K162767 | Sentinel BreastScan II System | First Sense Medical, LLC | 2017-01-09 | Special | PDF ↗ |
| K160573 | FirstSense Breast Exam | First Sense Medical, LLC | 2016-06-01 | Traditional | PDF ↗ |
| K150457 | AlfaSight 9000 Thermographic System | Alfa Thermodiagnostics, Inc. | 2015-04-10 | Traditional | PDF ↗ |
| K113259 | NOTOUCH BREASTSCAN | Ue Lifesciences, Inc. | 2012-02-10 | Traditional | PDF ↗ |
| K101641 | AG THERMOGRAPHIC CAMERA, MODEL ATIR-M301 | Ag Digital Technology Corp. | 2011-06-16 | Traditional | PDF ↗ |
| K073581 | ICI P AND S SERIES IR CAMERAS | Texas Infrared | 2008-07-11 | Traditional | PDF ↗ |
| K063047 | MEDHOT MTI 2000 THERMAL IMAGING SYSTEM | Medhot Thermal Imaging, Inc. | 2006-10-19 | Traditional | PDF ↗ |
| K050239 | EMD THERMOGRAPHY SYSTEM | Em Diagnostics, Inc. | 2006-03-16 | Traditional | PDF ↗ |
| K033967 | TELETHERMOGRAPHIC CAMERA, SERIES A, E, S AND P | Flir Systems | 2004-03-09 | Traditional | PDF ↗ |
| K032350 | INFRARED SCIENCES BREASTSCAN IR SYSTEM | Infrared Sciences Corp. | 2004-02-20 | Traditional | PDF ↗ |
| K032471 | TYTRON C-500IR CLINICAL INFRARED IMAGING SYSTEM | Titronics Research & Development Co. | 2003-10-10 | Traditional | PDF ↗ |
| K030165 | THERMATREK IRIS-IV INFRARED IMAGING SYSTEM | Thermatrek | 2003-04-16 | Traditional | PDF ↗ |
| K030018 | MHS 7000 | Micro Health Systems, Inc. | 2003-03-26 | Traditional | PDF ↗ |
| K023925 | MARK I THERMAL IMAGER | Ix-Dr, Inc. | 2003-02-11 | Traditional | PDF ↗ |
| K023434 | DOREX SPECTRUM 9000MB THERMOGRAPHY SYSTEM | Dorex, Inc. | 2002-11-14 | Special | PDF ↗ |
| K020783 | TELESIS DIGITAL INFRARED THERMAL IMAGE SYSTEM, SPECTRUM 9000MB | Telesis Technologies, Inc. | 2002-06-07 | Traditional | PDF ↗ |
| K011981 | MHS 5000 | Micro Health Systems, Inc. | 2001-09-05 | Traditional | PDF ↗ |
| K003332 | MEDITHERM MED2000 | Meditherm, Inc. | 2001-02-21 | Traditional | PDF ↗ |
| K003130 | REGUTHERM 952 THERMOGRAPHIC SYSTEM | Sie-Med, Inc. | 2001-02-16 | Traditional | PDF ↗ |
| K990416 | OMNICORDER BIOSCAN SYSTEM | Omnicorder Technologies, Inc. | 1999-12-23 | Traditional | PDF ↗ |
| K982112 | THERMATREK IRIS-3 INFRARED IMAGING SYSTEM | Thermatrek, Inc. | 1998-08-20 | Traditional | PDF ↗ |
| K982327 | INFRAMETRICS INFRACAM-MED | Inframetrics, Inc. | 1998-08-18 | Traditional | PDF ↗ |
| K971956 | CRT2000 THERMOGRAPHIC SYSTEM | Werner Eidam Medizin-Technologie GmbH | 1997-08-22 | Traditional | PDF ↗ |
| K951806 | OPGAL INTRAOPERATIVE VASCULAR ANGIOGRAPHY SYSTEM (IVA-2000) | Opgal Optronic Industries | 1995-07-06 | Traditional | PDF ↗ |
| K897191 | BSI MODEL TIP | Bales Scientific, Inc. | 1990-07-13 | Traditional | PDF ↗ |
| K895358 | THERMO-5000 | Medtronix Ltd., Inc. | 1990-05-07 | Traditional | PDF ↗ |
| K863818 | PM-100 THERMOGRAPH MARK 1026 | Clearwater Computer Center, Inc. | 1987-04-03 | Traditional | PDF ↗ |
| K861534 | MODEL 450 INFRARED IMAGING SYSTEM | Mitek , Inc. | 1986-07-18 | Traditional | PDF ↗ |
| K842878 | GST SYSTEM THERMOGRAPHIC APPLICATION | Gst Laboratories of Ca, Inc. | 1985-03-22 | Traditional | PDF ↗ |
| K844771 | INFRAVIEW/INFRASION-TELETHERMOGRAPHIC SYSTEM | Image Systems, Inc. | 1985-02-27 | Traditional | PDF ↗ |
| K850534 | BSI MODEL MCT 7000-THERMAL IMAGING SYSTEM | Bales Scientific, Inc. | 1985-02-27 | Traditional | PDF ↗ |
| K843549 | PROBEYE THERMAL VIDEO SYSTEMS | Hughes Aircraft Co. | 1985-02-11 | Traditional | PDF ↗ |
| K841271 | INFRA-EYE 160 | Fujitsu , Ltd. | 1984-07-28 | Traditional | PDF ↗ |
Product code LHQ · Class I · Obstetrics/Gynecology. Data: openFDA.