LHQ · System, Telethermographic (Adjunctive Use)
Obstetrics/Gynecology · 21 CFR 884.2980 · Class 1
Overview
| Product Code | LHQ |
|---|---|
| Device Name | System, Telethermographic (Adjunctive Use) |
| Regulation | 21 CFR 884.2980 |
| Device Class | Class 1 |
| Review Panel | Obstetrics/Gynecology |
Identification
A telethermographic system for adjunctive diagnostic screening for detection of breast cancer or other uses is an electrically powered device with a detector that is intended to measure, without touching the patient's skin, the self-emanating infrared radiation that reveals the temperature variations of the surface of the body. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.
Classification Rationale
Class I (general controls) for the adjunctive diagnostic screening system; Class III for the system intended for use alone in diagnostic screening.
Recent Cleared Devices (20 of 40)
Showing 20 most recent of 40 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K232462 | ThermPix Thermovisual Camera | Usa Therm, Inc. | Sep 14, 2023 | SESE |
| K213650 | ThermPix Thermovisual Camera | Usa Therm, Inc. | Apr 12, 2022 | SESE |
| K212965 | Smile-100 System | Niramai Health Analytix Private Limited | Mar 10, 2022 | SESE |
| K212412 | IRIS-XP | Medicore Co., Ltd. | Sep 13, 2021 | SESE |
| K200999 | Thermidas IR System (ThIR-A615) | Thermidas Americas, Inc. | Jan 6, 2021 | SESE |
| K181716 | InTouch Thermal Camera | Intouch Technologies, Inc., D.B.A. Intouch Health | Mar 25, 2019 | SESE |
| K171928 | Med-Hot Thermal Imaging Systems | Med-Hot Thermal Imaging, Inc. | Dec 8, 2017 | SESE |
| K162767 | Sentinel BreastScan II System | First Sense Medical, LLC | Jan 9, 2017 | SESE |
| K160573 | FirstSense Breast Exam | First Sense Medical, LLC | Jun 1, 2016 | SESE |
| K150457 | AlfaSight 9000 Thermographic System | Alfa Thermodiagnostics, Inc. | Apr 10, 2015 | SESE |
| K113259 | NOTOUCH BREASTSCAN | Ue Lifesciences, Inc. | Feb 10, 2012 | SESE |
| K101641 | AG THERMOGRAPHIC CAMERA, MODEL ATIR-M301 | Ag Digital Technology Corp. | Jun 16, 2011 | SESE |
| K073581 | ICI P AND S SERIES IR CAMERAS | Texas Infrared | Jul 11, 2008 | SESE |
| K063047 | MEDHOT MTI 2000 THERMAL IMAGING SYSTEM | Medhot Thermal Imaging, Inc. | Oct 19, 2006 | SESE |
| K050239 | EMD THERMOGRAPHY SYSTEM | Em Diagnostics, Inc. | Mar 16, 2006 | SESE |
| K033967 | TELETHERMOGRAPHIC CAMERA, SERIES A, E, S AND P | Flir Systems | Mar 9, 2004 | SESE |
| K032350 | INFRARED SCIENCES BREASTSCAN IR SYSTEM | Infrared Sciences Corp. | Feb 20, 2004 | SESE |
| K032471 | TYTRON C-500IR CLINICAL INFRARED IMAGING SYSTEM | Titronics Research & Development Co. | Oct 10, 2003 | SESE |
| K030165 | THERMATREK IRIS-IV INFRARED IMAGING SYSTEM | Thermatrek | Apr 16, 2003 | SESE |
| K030018 | MHS 7000 | Micro Health Systems, Inc. | Mar 26, 2003 | SESE |
Top Applicants
- Bales Scientific, Inc. — 2 clearances
- First Sense Medical, LLC — 2 clearances
- Micro Health Systems, Inc. — 2 clearances
- Usa Therm, Inc. — 2 clearances
- Ag Digital Technology Corp. — 1 clearance
