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The ThermPix Thermovisual Camera is intended to view, measure, and record heat patterns and variations. It is intended for use as adjunctive diagnostic imaging for thermally significant indications stemming from heat emitted from the human body. The significance of these thermal patterns and variations is determined by professional investigation. This device is intended for use by qualified technical personnel. Clinical judgement and experience are required to review and interpret the information transmitted. The ThermPix Thermovisual Camera is only for use in addition to other diagnostic medical devices. It does not provide any absolute measurement of temperature and should not be used for sole screening or diagnosis for any disease or condition. The system is not intended to be used as a thermometry device.

The ThermPix Thermovisual Camera is a Telethermographic system which consists of an infrared camera embedded in a Tablet case and a Commercial Off the Shelf Tablet (WIFF only). It is a non-contact, non-invasive, and non-radiating infrared system capable of imaging and storing thermal patterns generated by the human body. These images along with other patient-specific data are uploaded via WIFI to the ThermPix Cloud, a secure repository where clinicians can access and augment data from a 3rd party device or computer. It employs passive infrared emission sensing technology to capture the thermal data and uses proprietary software to display the temperature distribution pattern as an image. It is suitable for imaging adult human targets and can be used in hospitals, acute and sub-acute healthcare settings, clinics, and any environment where healthcare is provided by a healthcare professional.

The ThermPix Thermovisual Camera is intended to view, measure, and record heat patterns and variations. It is intended for use as adjunctive diagnostic imaging for themally significant indications stemming from heat emitted from the human body. The significance of these thermal pariations is determined by professional investigation. This device is intended for use by qualified technical personnel. Clinical judgement and experience are required to review and interpret the information transmitted. The ThermPix Thermovisual Camera is only for use in addition to other diagnostic medical devices. It does not provide any absolute measurement of temperature and should not be used for sole screening or diagnosis for any disease or condition. The system is not intended to be used as a thermometry device.

The ThermPix Thermovisual Camera is a Telethermographic system which consists of infrared and visual cameras and a touch-screen display. It is a non-contact, non-invasive, and non-radiating infrared system capable of imaging and storing thermal patterns generated by the human body. These images along with other patient-specific data are uploaded via Wifi to the ThermPix Cloud, a secure repository where clinicians can access and augment data from a 3rd party device or computer. It employs passive infrared emission sensing technology to capture the thermal data and uses proprietary software to display the temperature distribution pattern as an image. It is suitable for imaging adult human targets and can be used in hospitals, acute and sub-acute healthcare settings, clinics, and any environment where is provided by a healthcare professional.

SMILE-100 System is intended to review, measure and record skin temperature patterns and variations emitted from the human body. It is intended for use as adjunctive diagnostic imaging for themally significant indications in the breast region. The significance of the value of these thermal patterns is determined by profession. This device is intended for use by qualified healthcare personnel trained in its use. The system is not intended for absolute temperature measurements. The system is not intended to be used as a thermometry device.

The SMILE-100 System is a breast thermography device with a visualization tool that helps a healthcare personnel to review, measure and analyze thermally significant indications in the breast region. It is intended to be used in the hospital, acute care settings, outpatient surgery, healthcare practitioner facilities or an environment where patient care is provided by qualified healthcare personnel. SMILE-100 System consists of the following: - An off-the-shelf FDA cleared thermal camera with its associated camera control software (i) provided by the thermal camera vendor for capturing and viewing thermal images - An off the shelf laptop/desktop computer system with display, keyboard and mouse. (ii) - SMILE-100 Software for viewing thermal patterns in thermal images (iii) The SMILE-100 Software takes thermal images captured using off-the-shelf FDA-cleared thermal camera and provides various visualization options in multiple customizable views/palettes and also generates a report with quantitative thermal parameters and annotated images. The Software supports two user roles (i) a thermographer or imaging technician role and (ii) Expert thermologist role. The imaging technician captures thermal images and uploads them to the cloud-hosted SMILE-100 Software which performs image quality checks and submits to Expert. The Expert can select a temperature threshold for the SMILE-100 Software to highlight areas with thermal activity above the threshold in thermal images. The software makes no estimation of the thermal threshold. The software makes no determination regarding what the thermal patterns or relative temperature values mean. Expert thermologist needs to infer the meaning of high thermal activity and other areas of interest based on his/her visual interpretation of those patterns and thermal values.

The IRIS XP is a thermal based imaging device intended for measuring relative skin temperature generated by the human body in the clinical, hospital, acute care settings, surgery, healthcare practitioner facilities or in any environment where healthcare is provided by a qualified healthcare professional. (for adjunctive use only) The IRIS XP provides for use with both laptop and desktop computer provides the user interface, image storage and display. Use of this device is determined by the healthcare professional and is based upon his or her of the patient's medical condition and requirements. The patient populations include all assessment age groups from adult to pediatric and neonatal. The device is for providing thermal images of the human body. This device is intended for use by qualified healthcare personnel who are trained in its use. The system is not intended for absolute temperature measurements. The system is not intended to be used as a thermometry device.

IRIS-XP shows an image analysis on the display to measure the amount of infrared rays radiated from the patient. The appropriate color image according to the temperature difference is shown on the screen. The IRIS XP is intended for relative skin temperature measurements (temperature mapping) for adjunctive use only.

The Thermidas IR System is for adjunctive use in addition to other clinical diagnostic procedures for diagnostic imaging for thermally significant indications of all skin regions of the human body. The system is for reviewing and reporting of temperature patterns and changes. The significance of the value of these thermal patterns is determined by professional investigation. The system is not intended for absolute temperature measurements. The Thermidas IR system is intended for use by trained technical personnel.

The Thermidas IR System consists of an off-the-shelf thermal imaging camera, a mount for the camera and a Windows workstation running the Thermidas Imager software. The Thermidas IR System is a non-invasive medical device which uses infrared radiation naturally emitted by the patient, which senses variations in temperature. The captured data is processed by software producing a quantitative image on the computer screen. The medical professional can use the image to review, analyze, investigate, and quantify the temperature of the objects that are imaged.

The InTouch Thermal Camera is intended to view, measure and record heat patterns and variations. It is intended for use as adjunctive diagnostic imaging for thermally significant indications stemming from heat emitted from the human body. The significance of these thermal patterns and variations is determined by profession. This device is intended for use by qualified technical personnel trained in its use. Clinical judgment and experience are required to review and interpret the information transmitted. The InTouch Thermal Camera is only for use in addition to other medical devices (i.e. Thermometer, Ultrasound, Mammography). It does not provide any absolute measurement of temperature and should not be used for sole screening or diagnosis for any disease or condition.

The InTouch Thermal Camera™ is a hardware and software package that enables thermographic imagery and data during a real-time telemedicine consultation. The system includes a 320-pixel-wide thermal camera and a USB cable that allows connection of the camera to a Windows-based computer, which serves as the patientside InTouch Health Telemedicine Device. The InTouch Thermal Camera software consists of two components. The first is installed on a Windows-based system to serve as the InTouch Health Telemedicine Device. The second component is installed on a Windows or iOS-based system serving as the InTouch Health Provider Access device, enabling a healthcare professional access to the InTouch Health Telemedicine Device. The core software serves as a telecommunications platform that enables real-time videoconferencing and clinical communications, and provides a means of transmitting, receiving, and storing real-time audio and video data. The InTouch Health Telemedicine System software provides a real-time link between the patient and the healthcare professional(s). The link occurs over a wired or wireless broadband connection, and includes real-time audio and video to facilitate communication between the patient-side healthcare professionals, and remote healthcare professional(s). The InTouch Health software further provides an ability to toggle between an InTouch Health Telemedicine Device's optical camera and the InTouch Thermal Camera, or to view both simultaneously. When utilizing the InTouch Thermal Camera, the clinician is provided with interface controls to allow a variety of options in the visualization of the thermal imagery. The basic purpose of the InTouch Thermal Camera is to allow a physician to view the heat pattern of a patient, while engaged in a telemedicine consultation. When the InTouch Thermal Camera is engaged, the InTouch Health software provides the physician with a variety of controls for visualizing temperature patterns and temperature differences.

The Med-Hot Thermal Imaging Systems are intended to review, measure and record skin temperature patterns and variations emitted from the human body. They are intended for use as adjunctive diagnostic imaging for thermally significant indications in the regions of the head and neck, breast, chest, abdomen, back and extremities. The value of the value of these thermal patterns is determined by professional investigation. This device is intended for use by qualified technical personnel trained in its use.

The Med-Hot Thermal Imaging Systems are non-contact infrared imaging devices, with all functions controlled at the computer screen. TotalVision is a patented, clinical personnel friendly software application, validated in the field. The system is delivered with a computer including installed and tested software. The Med-Hot Thermal Imaging camera is suitable for high quality imaging of the human body. The TotalVision Capture Software allows for incoming image data from the camera head and configures that data in a form that can be displayed on the computer screen. This display will include an image of the scene within the camera's field of view allowing the user to visualize thermal patterns or analyze the image in terms relative temperature values. The software makes no determination regarding what the thermal patterns or relative temperature values mean. It will be left to the user to infer areas of interest based on his/her visual interpretation of those patterns or values. The new device consists of: 1. Infrared Camera (MAX 076 320 x 240 array detector or MAX 307 640 x 480 array detector), 2. TotalVision Software, 3. Laptop or desktop computer.

The Sentinel BreastScan II System is intended for viewing and recording heat patterns generated by the human body in the hospital, acute care settings, outpatient surgery, healthcare practitioner facilities or in an environment where patient care is provided by qualified healthcare personnel. The patient populations include adult. The device is for adjunctive diagnostic screening for detection of breast cancer and diseases affecting blood perfusion or reperfusion of tissue or organs. This device is intended for use by qualified healthcare personnel trained in its use.

The Sentinel BreastScan II System consists of a portable device that captures and records thermal infrared energy (heat) emitting from a person's body. There is no compression of the breast or patient contact with the device and the test emits no radiation to the patient. The device consists of a thermal camera, a metal enclosure to secure and protect components, a motor and electronics to raise and lower the tester to adjust the camera for various sized patients, a chair with attached armrests, adjustable special heat reflecting mirrors, a computer with a touchscreen monitor, data storage, software, and Wi-Fi communication. The tester includes an air cooling unit that blows cool air during part of the test cycle.

The FIRSTSense Breast Exam® device is intended for viewing and recording heat patterns generated by the human body in the hospital, acute care settings, outpatient surgery, healthcare practitioner facilities, or in an environment where patient care is provided by qualified healthcare personnel. It is intended for use in adult patient populations. The device is for adjunctive diagnostic screening for detection of breast cancer and diseases affecting blood perfusion of tissue or organs. This device is intended for use by qualified healthcare personnel trained in its use.

The FirstSense Breast Exam® system consists of a portable device (FSBE Tester) that captures and records thermal infrared energy (heat) emitting from a person's body. There is no compression of the breast or patient contact during a screening test. The device emits no radiation to the patient. The device consists of a thermal camera, a 3D camera, a tester main body consisting of metal and plastic to safely and securely house the electronic and mechanical components and motors (to adjust cameras for various sized patients), a computer, software components and two color monitors, as well as an air cooling unit that blows cool air during part of the screening test cycle. The FSBE system also contains a cloud server for safe storage of test data. During a screening test, the FSBE Tester's thermal camera acquires thermal images, and the 3D camera acquires depth data and visible light images of the patient breasts. When a test is completed, the acquired data is uploaded to the FSBE system's cloud server, the FSM Central Server. The uploaded data becomes available to a physician when the FirstSense Data Viewer (FSDV) application downloads the data from the server to a local computer. The FSDV application allows the physician to view the thermal images, the 3D depth image and visible RGB images of the patient breasts. The depth and visible images are provided to the physician as additional information about the breasts with no quantitative data. When the FSDV application provides the thermal images, it allows the application user to select breast regions (nipple, areola, whole breast quadrants) and regions of interest on the thermal views. The FSDV application provides temperature differential data between the left and right breast regions, and temperature differential data for the regions of interest before and after blowing cool air to the breasts in Test Summary report. The FSDV allows the application user to enter threshold values to be compared to the calculated temperature differential data. The FSDV provides comments in the Test Summary Report to indicate that the temperature differential data is within or above the entered threshold value. The FSDV does not include default threshold values and does not provide comments in the Test Summary report should the user choose not to enter threshold values.

The AlfaSight 9000 is intended for the adjunct diagnosis of the female breast; 2) peripheral vascular disease; 3) musculoskeletal disorders; 4) extracranial cerebral and facial vascular disease; 5) abnormalities of the thyroid gland; and 6) various neoplastic and inflammatory conditions. The AlfaSight 9000 is not intended to serve as a sole diagnostic screening procedure.

The AlfaSight 9000 system is a non-invasive, handheld and battery-operated adjunctive diagnostic device that measures and records skin surface temperatures. The system is intended for use as an adjunct to other clinical diagnostic procedures to quantify relative skin surface temperatures. It is not intended as a sole diagnostic device and does not replace or substitute any clinical test or device such as X-Ray, CT scans, mammography or other similar equipment. The system is for prescription-only use by licensed medical practitioners for use in hospitals, sub-acute healthcare settings, and private clinics. The AlfaSight 9000 system consists of: 1) a handheld probe, 2) an off-the-shelf computer 3) a standard USB charging cable and 4) biocompatible sheaths. The single use theath is placed over the handheld probe covering the entire probe, three capacitive pins sense contact of the skin through the sheath to start the temperature measurement. Temperature samples are then sent from the handheld probe to the computer wirelessly using Bluetooth technology and are represented in a graphical display on the computer. Samples are organized into specified regions of the body as they are sampled in a fixed order as directed by the software.