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510(k) Data Aggregation
K Number
K240610Device Name
deepLive
Manufacturer
DAMAE Medical
Date Cleared
2024-07-09
(126 days)
Product Code
NQQ, NOO
Regulation Number
892.1560Why did this record match?
Applicant Name (Manufacturer) :
DAMAE Medical
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
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.
Device Description
deepLive was designed for an easy integration into clinical practices. The device is composed of:
- A. A mobile cart, allowing the user to move the whole device and including a cart tablet for accessories.
- B. A touchscreen, fixed on the cart mast, displaying the software interfaces to the user.
- C. A hand-held probe, 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. The probe is the interface between the device, the doctor and the patient: its measuring head (tip) must be positioned in contact with the patient's skin.
- D. 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.
- E. 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.
The secured access to the computer operating system, deepLive software and data folders are managed by Windows sessions authentication system. The computer hosting deepLive is also likely to have applications installed by DAMAE Medical:
- · Synology Drive: used to retrieve device data for maintenance and software improvement purposes.
- TeamViewer: remote control software used for software manual update and software issues solving.
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