Product code LHQ
- Device name
- System, Telethermographic (Adjunctive Use)
- Medical specialty
- Obstetrics/Gynecology
- Device class
- 1
- Regulation number
- 884.2980
- Review panel
- RA
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253911 | Derma-2 | Neko Health AB | 2026-05-20 |
| K232462 | ThermPix Thermovisual Camera | Usa Therm, Inc. | 2023-09-14 |
| K213650 | ThermPix Thermovisual Camera | Usa Therm, Inc. | 2022-04-12 |
| K212965 | Smile-100 System | Niramai Health Analytix Private Limited | 2022-03-10 |
| K212412 | IRIS-XP | Medicore Co., Ltd. | 2021-09-13 |
| K200999 | Thermidas IR System (ThIR-A615) | Thermidas Americas, Inc. | 2021-01-06 |
| K181716 | InTouch Thermal Camera | Intouch Technologies, Inc., D.B.A. Intouch Health | 2019-03-25 |
| K171928 | Med-Hot Thermal Imaging Systems | Med-Hot Thermal Imaging, Inc. | 2017-12-08 |
| K162767 | Sentinel BreastScan II System | First Sense Medical, LLC | 2017-01-09 |
| K160573 | FirstSense Breast Exam | First Sense Medical, LLC | 2016-06-01 |
| K150457 | AlfaSight 9000 Thermographic System | Alfa Thermodiagnostics, Inc. | 2015-04-10 |
| K113259 | NOTOUCH BREASTSCAN | Ue Lifesciences, Inc. | 2012-02-10 |
| K101641 | AG THERMOGRAPHIC CAMERA, MODEL ATIR-M301 | Ag Digital Technology Corp. | 2011-06-16 |
| K073581 | ICI P AND S SERIES IR CAMERAS | Texas Infrared | 2008-07-11 |
| K063047 | MEDHOT MTI 2000 THERMAL IMAGING SYSTEM | Medhot Thermal Imaging, Inc. | 2006-10-19 |
| K050239 | EMD THERMOGRAPHY SYSTEM | Em Diagnostics, Inc. | 2006-03-16 |
| K033967 | TELETHERMOGRAPHIC CAMERA, SERIES A, E, S AND P | Flir Systems | 2004-03-09 |
| K032350 | INFRARED SCIENCES BREASTSCAN IR SYSTEM | Infrared Sciences Corp. | 2004-02-20 |
| K032471 | TYTRON C-500IR CLINICAL INFRARED IMAGING SYSTEM | Titronics Research & Development Co. | 2003-10-10 |
| K030165 | THERMATREK IRIS-IV INFRARED IMAGING SYSTEM | Thermatrek | 2003-04-16 |
| K030018 | MHS 7000 | Micro Health Systems, Inc. | 2003-03-26 |
| K023925 | MARK I THERMAL IMAGER | Ix-Dr, Inc. | 2003-02-11 |
| K023434 | DOREX SPECTRUM 9000MB THERMOGRAPHY SYSTEM | Dorex, Inc. | 2002-11-14 |
| K020783 | TELESIS DIGITAL INFRARED THERMAL IMAGE SYSTEM, SPECTRUM 9000MB | Telesis Technologies, Inc. | 2002-06-07 |
| K011981 | MHS 5000 | Micro Health Systems, Inc. | 2001-09-05 |
| K003332 | MEDITHERM MED2000 | Meditherm, Inc. | 2001-02-21 |
| K003130 | REGUTHERM 952 THERMOGRAPHIC SYSTEM | Sie-Med, Inc. | 2001-02-16 |
| K990416 | OMNICORDER BIOSCAN SYSTEM | Omnicorder Technologies, Inc. | 1999-12-23 |
| K982112 | THERMATREK IRIS-3 INFRARED IMAGING SYSTEM | Thermatrek, Inc. | 1998-08-20 |
| K982327 | INFRAMETRICS INFRACAM-MED | Inframetrics, Inc. | 1998-08-18 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| B783706400170601189 | Meditherm | Meditherm Incorporated | 2026-05-18 |
| B783706400170601185 | Meditherm | Meditherm Incorporated | 2026-05-01 |
| B783706400170601158 | Meditherm | Meditherm Incorporated | 2026-03-31 |
| B783706400170601159 | Meditherm | Meditherm Incorporated | 2026-03-23 |
| B783706400170601152 | Meditherm | Meditherm Incorporated | 2026-03-18 |
| B783706400170601154 | Meditherm | Meditherm Incorporated | 2026-03-18 |
| 00860008801906 | ThermPix | USA THERM, INC. | 2026-01-27 |
| B783706400170601148 | Meditherm | Meditherm Incorporated | 2025-12-22 |
| B783706400170601149 | Meditherm | Meditherm Incorporated | 2025-12-22 |
| 08908019450118 | BreastHealth-100 | NIRAMAI HEALTH ANALYTIX PRIVATE LIMITED | 2025-11-21 |
| B783706400170601151 | Meditherm | Meditherm Incorporated | 2025-07-30 |
| B783706400170601142 | Meditherm | Meditherm Incorporated | 2025-07-23 |
| B783706400170601147 | Meditherm | Meditherm Incorporated | 2025-07-23 |
| B783706400170601146 | Meditherm | Meditherm Incorporated | 2025-07-23 |
| B783706400170601145 | Meditherm | Meditherm Incorporated | 2025-07-23 |
| B783706400170601141 | Meditherm | Meditherm Incorporated | 2025-07-23 |
| B783706400170601132 | Meditherm | Meditherm Incorporated | 2025-07-02 |
| B783706400170601144 | Meditherm | Meditherm Incorporated | 2025-07-02 |
| B783706400170601140 | Meditherm | Meditherm Incorporated | 2025-05-08 |
| B783706400170601143 | Meditherm | Meditherm Incorporated | 2025-05-08 |
| 06429810718037 | Thermidas | TherMidas Oy | 2025-04-08 |
| 06429810718044 | Thermidas | TherMidas Oy | 2025-04-08 |
| B783706400170601133 | Meditherm | Meditherm Incorporated | 2025-02-24 |
| B783706400170601136 | Meditherm | Meditherm Incorporated | 2025-02-24 |
| B783706400170601137 | Meditherm | Meditherm Incorporated | 2025-02-24 |
| 08908019450057 | SMILE-100 System | NIRAMAI HEALTH ANALYTIX PRIVATE LIMITED | 2025-02-18 |
| B783706400170601138 | Meditherm | Meditherm Incorporated | 2024-10-25 |
| B783706400170601135 | Meditherm | Meditherm Incorporated | 2024-09-09 |
| 00853818007507 | USB C to C Cable | PRECISION BIOMETRICS INC | 2024-09-03 |
| 10853818007504 | USB C Adapter | PRECISION BIOMETRICS INC | 2024-09-03 |