LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K251893

    Validate with FDA (Live)

    Device Name
    SKAN C PULSAR
    Manufacturer
    Skanray Technologies Limited
    Date Cleared
    2025-12-16

    (179 days)

    Product Code
    OWB,JAA,OXO
    Regulation Number
    892.1650
    Type
    Traditional
    Panel
    Radiology
    Age Range
    0 - 150
    Reference & Predicate Devices
    K200218,K181560,K230871,K170946
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The SKAN C Pulsar, a Mobile Surgical C-Arm X-Ray System, is intended to provide Fluoroscopic images of patients during Diagnostic, Surgical and Interventional procedures. SKAN C Pulsar is to be used by adequately trained, qualified and authorized healthcare professionals. Clinical Applications may include Orthopedic, GI Procedure, Neurology, Urology Procedures, Vascular in Critical Care and Emergency Room Procedures.

    SKAN C Pulsar is not recommended for Cardiac Applications.

    SKAN C Pulsar surgical C-Arm is indicated for visualization in real time and/or recording of surgical region of interest and anatomy, using X-ray imaging technique.

    Device Description

    The SKAN C Pulsar, a Mobile C-Arm X-Ray System, is intended to provide Fluoroscopic images of patients during Diagnostic, Surgical and Interventional procedures. SKAN C Pulsar is to be used by adequately trained, qualified and authorized healthcare professionals. Clinical Applications may include Orthopedic, GI Procedure, Neurology, Urology Procedures, Vascular in Critical Care and Emergency Room Procedures.

    SKAN C Pulsar is a Mobile fluoroscopy C-Arm consisting of two main units:
    a) C-arm main unit
    b) A Workstation or Monitor Cart

    The C-arm unit is composed of an X-ray tube, a flat panel detector, a collimator, a generator, a touch panel, foot switch, hand switch and a Console. C-arm has provision for mechanical movement of C-arm for Orbital and Yoke Rotation along with vertical and wig-wag movements.

    Workstation or Monitor cart is composed of a monitor, keyboard and computing system.

    The operating principle of the device is to expose X-ray, which are passed through the human body and falls on the sensor. The intensity of X-ray can be adjusted to required level. Detector follows two step conversion. It converts X-ray into light and Light is converted into electrical signal. Electrical signal is than digitized and stored. This stored information is processed and displayed on the monitor. The displayed images can be saved or transmitted to an external storage device.

    AI/ML Overview

    N/A

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1