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510(k) Data Aggregation

    K Number
    K251678

    Validate with FDA (Live)

    Device Name
    Swift Ray 1
    Date Cleared
    2026-02-24

    (270 days)

    Product Code
    Regulation Number
    878.4550
    Age Range
    All
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Swift Ray 1 is a portable digital imaging device that allow clinicians diagnosing and treating wounds, at the point of care, to:

    i. View and digitally record images of a wound,
    ii. Digitally measure and record the size of the wound
    iii. View and record digital images of fluorescence emitted from the wound when exposed to an excitation light, and
    iv. View and record thermographic images and measure temperature differences within the image using long-wave infrared technology

    The fluorescence image, when used in combination with clinical signs and symptoms, has been shown to increase the likelihood that clinicians can identify wounds containing bacterial loads >10^4 CFU per gram as compared to examination of clinical signs and symptoms alone.

    The Swift Ray 1 device should not be used to rule-out the presence of bacteria in a wound.
    The Swift Ray 1 does not diagnose or treat skin wounds

    Device Description

    The Swift Ray 1 is a portable digital imaging system designed for use by clinicians at the point of care to assist in the assessment and documentation of wounds. The device integrates high-resolution digital imaging, fluorescence imaging, and thermographic imaging to capture visual, fluorescent, and thermal data from wounds.

    Clinicians can view, measure, and record wound size, as well as detect fluorescence emitted by tissue when exposed to specific excitation light. When used alongside clinical signs and symptoms, fluorescence imaging with Swift Ray 1 has been shown to increase the likelihood of identifying wounds with bacterial loads greater than 10⁴ CFU/gram. Additionally, the device captures thermographic images to support visualization of temperature variations across the wound site. Swift Ray 1 is not intended to diagnose or treat wounds, nor should it be used to rule out the presence of bacteria. It operates in combination with Swift's secure software platform, enabling real-time analysis and EMR-compatible documentation.

    AI/ML Overview

    N/A

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