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510(k) Data Aggregation

    K Number
    K253029

    Validate with FDA (Live)

    Device Name
    RW-1
    Manufacturer
    Mediott, Inc.
    Date Cleared
    2026-03-31

    (193 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Type
    Traditional
    Panel
    Radiology
    Age Range
    18 - 150
    Reference & Predicate Devices
    K212685
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    This software is a medical device intended for the visualization of various intensity modulation including FFT filter. It receives, stores, processes, and displays sequential DICOM images primarily obtained through low-dose chest fluoroscopy (e.g., RF and AX modalities).

    This software is not intended to be used for primary diagnosis. Reference images such as scintigraphy or CT scans may be displayed for supplementary purposes. This software is intended for use in adult patients only.

    Device Description

    The subject device is the software device that receives, stores, processes, and displays sequential DICOM images including the intensity modulation primarily obtained through chest fluoroscopy (e.g., RF and AX modalities). The software is compatible with external systems such as hospital PACS via DICOM-compliant communication protocols.

    The device incorporates a intensity modulation mode image including fast Fourier transform (FFT), which extracts time-varying components corresponding to lower and higher frequency band pass filter in chest XP dynamics. When appropriate image acquisition conditions are met (e.g., fixed exposure, no post-processing, sufficient number of frames), the software generates differential projection images:

    • RDP (Lower frequency band pass filter modulated projection in chest XP dynamic imaging)
    • BDP (Higher frequency band pass filter modulated projection in chest XP dynamic imaging)

    Additionally, the software can compute time-compressed summary images (e.g., MEDP, MIDP, MBDP), which provide intuitive visualization of regional changes, similar to maximum intensity projection techniques used in CT imaging. The device operates as a standalone application, with all processing and visualization of the intensity modulation integrated into a single software package.

    AI/ML Overview

    N/A

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