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510(k) Data Aggregation

    K Number
    K253182
    Device Name
    InkSpace Imaging Small Body Array (SBA12PH30x)
    Manufacturer
    InkSpace Imaging, Inc.
    Date Cleared
    2025-10-20

    (24 days)

    Product Code
    MOS
    Regulation Number
    892.1000
    Type
    Special
    Panel
    Radiology
    Reference & Predicate Devices
    K233444
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The InkSpace Imaging Small Body Array is a receive-only coil, used for obtaining diagnostic images of general human anatomy, such as cardiac, hip, shoulder, liver, knee, and ankle in Philips 3.0T magnetic resonance imaging systems. These images, when interpreted by a trained physician, yield information that may assist in diagnosis.

    Device Description

    The InkSpace Imaging Small Body Array is a phased array, receive-only coil designed to work on Philips 3.0 Tesla (3.0T) MRI scanners. It consists of 12 elements which are optimized to be lightweight and flexible to easily conform to a patient's anatomy, providing high signal-to-noise ratio. The elements are enclosed in a soft padded pouch which can be wiped clean. The array is designed for proton imaging at 3.0 Tesla and has an optimal field of view of 27x25cm.

    AI/ML Overview

    N/A

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