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510(k) Data Aggregation

    K Number
    K232891
    Device Name
    CARPL (CARPL)
    Manufacturer
    Date Cleared
    2024-03-27

    (191 days)

    Product Code
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    Carpl AI Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    CARPL, a web-based PACS and radiology workflow management device, used for viewing and assessing DICOM images Ex: DX, DR, CR, CT, MR, US, RF and 2D/3D mammography. It gathers digital images and information from a variety of sources that adhere to the DICOM standard. These sources encompass a range of devices, including digital and computed radiographic equipment, CT and MR scanners, ultrasound and RF machines, PET units, secondary capture tools, imaging gateways. CARPL enables the storage, transmission, and visualization of images and data within the system itself or over computer networks spanning different locations. Only pre-processed DICOM images specifically intended for presentation are suitable for primary image diagnosis in mammography. Lossy compressed Mammographic images and digitized film screen images must not be reviewed for primary interpretation on the CARPL. To ensure accurate interpretation, mammographic images should only be evaluated on a monitor that adheres to the technical specifications outlined by the FDA. This system is designed exclusively for use by proficient and certified medical experts, including physicians, radiologists, and medical technicians.
    Device Description
    CARPL, a web-based PACS and radiology workflow management device, used for viewing and assessing DICOM images Ex: DX, DR, CR, CT, MR, US, RF and 2D/3D mammography. It gathers digital images and information from a variety of sources that adhere to the DICOM standard. These sources encompass a range of devices, including digital and computed radiographic equipment, CT and MR scanners, ultrasound and RF machines, PET units, secondary capture tools, imaging gateways. CARPL enables the storage, transmission, processing, and visualization of images and data within the system itself or over computer networks spanning different locations. Only preprocessed DICOM "for presentation" images can be interpreted for primary image diagnosis in mammography. Mammographic images with lossy compression and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using a display that is cleared, and that meets technical specifications reviewed and accepted by your regulatory authorities. Preprocessing occurs during the transfer of DICOM images from PACS to CARPL Platform involving the filtering of data based on the DICOM tags like "Modality", "Study Description", "Accession Number", etc. This process is aimed at extracting DICOM images that align with the requirements of the deployment workflow. Images that have not undergone this preprocessing are not included in the deployment workflow. CARPL accepts digital images and information from various sources that adhere to the DICOM standard. These sources include CT scanners, MR scanners, ultrasound systems, RF Units, PET Units, computed and digital radiographic devices, secondary capture devices, imaging gateways, and other imaging equipment. The system features post-processing elements like MPR/MIP that improve visualization for radiologists, aiding them in the diagnostic assessment and measurement of Computed Tomography (CT) and Magnetic Resonance (MR) images. When assessing images for diagnostic purposes, it becomes the duty of the healthcare expert to ascertain whether the image quality is appropriate for clinical use. The system offers the choice to incorporate third-party AI models that have been cleared by the FDA. A regulatory compliance team continually oversees and verifies the clearance status of each algorithm. Each algorithm developer must prove regulatory clearances before their products can be incorporated with CARPL. FDA-cleared 3rd party algorithms listed in CARPL display the FDA clearance "K" number along with a hyperlink to the algorithm's FDA clearance URL. The solution solely aids in visualizing the outcomes of these third-party AI models without modifications. The safety and efficacy of the third-party model are governed by the regulatory approval granted to the original manufacturer of the said model. CARPL's integrated FDA-cleared algorithm list is exclusively managed by CARPL.AI Customers do not have the ability technically or administratively to add or modify which FDA-cleared AI algorithms are integrated with CARPL. Only FDA-cleared algorithms which have passed rigorous regulatory and quality standards review by CARPL.AI Inc. to guarantee functionality, safety and security are made available in CARPL. CARPL simply presents the simple AI response output, and the initial anonymized image remains consistently available. The duty of evaluating the AI output, validating the results, and conducting the diagnosis lies with competent medical professionals.
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