Search Results
Found 2 results
510(k) Data Aggregation
K Number
K181716Device Name
InTouch Thermal Camera
Date Cleared
2019-03-25
(270 days)
Regulation Number
884.2980Why did this record match?
Applicant Name (Manufacturer) :
InTouch Technologies, Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
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.
Device Description
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.
Ask a Question
Ask a specific question about this device
K Number
K073710Device Name
INTOUCH REMOTE PRESENCE ROBOTIC SYSTEM, MODEL RP-7
Manufacturer
Date Cleared
2008-04-11
(102 days)
Product Code
Regulation Number
870.2910Why did this record match?
Applicant Name (Manufacturer) :
INTOUCH TECHNOLOGIES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Remote Presence Robotic System is a communications tool that provides a means of transmitting, receiving, and storing real-time audio and video, and patient data. The Remote Presence Robotic also can be used in conjunction with 510(k)-cleared devices that transmit patient biometric data including vital signs information. The Remote Presence Robotic System transmits and receives information over high speed connection between patients and health professional, and is intended to be used in a hospital or clinic environment. Clinical judgment and experience are required to review and interpret the information transmitted.
Device Description
The Remote Presence Robotic System is a mobile, robotic telecommunications platform that enables real-time videoconferencing. The Remote Presence Robotic System consists of a ControlStation (a desktop or laptop computer) and the RP-7 mobile robot, which is most often linked via broadband Internet and an 802.11 wireless network. The Robot and ControlStation are each equipped with cameras, displays, microphones and speakers, allowing two-way audio-video communication. Additionally, the ControlStation is equipped with a joystick that the operator uses to control the movement of the Robot in the remote location. As a result, the user can move through a remote facility and engage in conversations as if physically present while seated at a ControlStation in a remote facility with broadband Internet access. As an option, the Remote Presence Robotic System includes an integrated electronic stethoscope. The stethoscope is a FDA-cleared device which is used for the same purpose for which it received 510(k) clearance, i.e., to transmit auscultation sounds from a patient at one location to a clinic at a different location. The System provides a channel for the digital data that the stethoscope transmits.
Ask a Question
Ask a specific question about this device
Page 1 of 1