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deepLive is intended to be used as a non-invasive imaging tool in the evaluation of external human tissue microstructure by providing three-dimensional, cross-sectional and en-face real-time depth visualization for assessment by physicians to support in forming a clinical judgment.

The deepLive device is an update to the previously cleared deepLive device (K240610). The update includes the addition of a hand-held Dermoscope (DMS).

deepLive was designed for an easy integration into clinical practices. The device is composed of:

• A mobile cart, allowing the user to move the whole device and including a cart tablet for accessories.
• A touchscreen, fixed on the cart mast, displaying the software interfaces to the user.
• A first hand-held probe (LC-OCT), integrating the LC-OCT imaging system (interferometric microscope, OCT camera). The probe is connected to the CPU front panel by a sheathed cable bundle, and stored in a dedicated probe-holder fixed on the cart tablet.
• A second hand-held probe (DMS), complementary to the LC-OCT, integrating a dermoscope and providing wide-field surface color images. The probe is connected to the CPU by a USB cable, and stored in a dedicated probe-holder fixed on the cart tablet.
• A central power unit (CPU), mounted on the cart, integrating various imaging and electronic peripherals (laser, computer, electronic cards, drivers, power supplies, etc.), driving and powering the imaging probe.
• A software running on the device's computer, which controls the components of the system, acquires and processes images, and provides user interfaces for performing examinations and managing data.

deepLive hardware interfaces are located on the front-panel of the CPU. Input/output connections include:

• 1 Display port to connect the screen
• 3 USB ports to connect external drives (Wifi key, hard drive disk, etc.)

deepLive software runs on a computer embedded in the CPU of the device. The computer uses Windows Enterprise LTSC operating system. The software executable and all dynamic libraries needed for program execution are deployed at a specific location in the file system.

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