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510(k) Data Aggregation

    K Number
    K221309
    Device Name
    AI100 with Shonit
    Manufacturer
    SigTuple Technologies Pvt. Ltd.
    Date Cleared
    2023-09-19

    (502 days)

    Product Code
    JOY
    Regulation Number
    864.5260
    Why did this record match?
    Applicant Name (Manufacturer) :

    SigTuple Technologies Pvt. Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    AI100 with Shonit™ is a cell locating device intended for in-vitro diagnostic use in clinical laboratories. A1100 with Shonit™ is intended for differential count of White Blood Cells (WBC), characterization of Red Blood Cells (RBC) morphology and Platelet morphology. It automatically locates blood cells on peripheral blood smears and presents images of the blood cells for review. A skilled operator, trained in the use of the device and in the review of blood cells, identifies each cell according to type.
    Device Description
    The AI100 with Shonit™ device consists of a high-resolution microscope with LED illumination, and compute parts such as the motherboard, CPU, RAM, Wi-Fi dongle, SSD containing AI100 with Shonit™ software, motorized XYZ stage, a camera with firmware, PCB and its firmware for driving motor and LED, SMPS, power supply and a casing. It is capable of handling one Peripheral Blood Smear (PBS) slide at a time. Software plays an intrinsic role in the A1100 with Shonit™ device, and the combination of hardware and software works together for the device to achieve its intended use. The main functions of the software can be summarized as follows: - Allow the user to set up the device and perform imaging of a PBS slide. ● - Control the hardware components (Camera, LEDs, Stages, etc) to take images of a . PBS slide. - Store and manage images and other data corresponding to the PBS slide and present them to the user. - Analyze images and allows user to identify components in the images and create a ● report for review. - Allow the user to finalize, download and print a report.
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