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510(k) Data Aggregation

    K Number
    K251168
    Device Name
    Image Suite
    Manufacturer
    Carestream Health Inc.
    Date Cleared
    2025-09-04

    (142 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K120062,K133442,K163157,K140271
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Image Suite is a stand-alone radiographic imaging software designed to perform patient registration, review, report, archive, and print patient images. The software interacts with Carestream CR or DR to receive radiographic images for review, and has the ability to receive, archive, and review DICOM images from compatible third-party modalities (for example, US, MR, CT). The software can also update Carestream CR or DR device firmware and monitor device calibration. The software serves as a web server to support web clients for image viewing. Image Suite is intended for use by radiologists and trained healthcare professionals. The software presents images to medical professionals in a convenient digital medium so they can make diagnostic and/or therapeutic decisions.

    This excludes mammography applications and Tablet Viewer applications in the United States.

    Device Description

    Image Suite software is a Picture Archiving and Communication System (PACS) that allows patient registration, image acquisition, processing, reviewing, reporting, archiving and printing of radiographic images from compatible Carestream image acquisition devices, such as digital radiography (DR) detectors or computed radiography (CR) systems. In addition to being designed to function with images acquired from Carestream compatible devices, Image Suite can receive DICOM images from compatible third-party modalities (for example, Ultrasound, MRI, CT). Third party images may be viewed and archived by Image Suite, but no changes to the raw image from the third-party device are possible.

    This Image Suite submission adds features that are commercially available on other Carestream products. Image Suite utilizes the same image processing software (Eclipse) as the Carestream CR and DR devices that the features being detailed in this submission were previously cleared on.

    These features include:

    • Companion Imaging
      • Tube & PICC Line /High Detail Visualization/Skeletal Enhancement (commercially available option in x-ray systems under K120062)
      • Pneumothorax visualization (does not detect the pneumothorax) (commercially available option in x-ray systems K120062)
      • Bone Suppression (previously cleared in K133442)
    • Multiple Looks (subset of the looks provided in the commercially available x-ray systems)
    • Smart Grid (cleared under K163157).

    This submission will also address cumulative changes made since the last 510(k) submission K140271. Over time minor changes have been made to the Image Suite product that have not impacted safety or effectiveness of the product.

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