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510(k) Data Aggregation

    K Number
    K251030
    Device Name
    Sirona Advanced Imaging Suite
    Manufacturer
    Sirona Medical
    Date Cleared
    2025-10-22

    (202 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K101342
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Sirona Advanced Imaging Suite is a Medical Image Management and Processing System and consists of four PET (Positron Emission Tomography) viewing features which is used for the viewing, registration, fusion, and/or display for diagnosis of medical images from the following modalities: PET and CT.

    These features are as follows:

    • a. PET-CT overlay/fusion
    • b. Measurement of Standardized Uptake Value on PET image series and generated PET-CT overlay/fusion
    • c. Maximum Intensity Reconstruction of PET image series
    • d. Multiplanar Reconstruction of PET image series and PET-CT overlay/fusion

    Sirona Advanced Imaging Suite is intended to be used with the Sirona PACS (or MIMPS) Viewer.

    The intended users of the PET Module are trained radiologists, medical professionals, or other healthcare providers within a healthcare organization.

    Device Description

    Sirona Advanced Imaging Suite is a software-based imaging solution designed to facilitate the review, analysis, and interpretation of positron emission tomography (PET) and computed tomography (CT) imaging studies. Intended to be used with the Sirona PACS (or MIMPS) Viewer, this module enables healthcare professionals, including radiologists and nuclear medicine physicians, to visualize, manipulate, and analyze multi-modality medical images for diagnostic and clinical decision-making. Sirona Advanced Imaging Suite provides image fusion and co-registration capabilities, allowing users to overlay PET and CT images for combined anatomical and functional assessment. It supports multi-planar reconstructions (MPRs), maximum intensity projections (MIP), and standardized uptake value (SUV) calculations for metabolic activity assessment. The software is fully compatible with DICOM standards, ensuring seamless integration with imaging modalities and healthcare IT infrastructure.

    AI/ML Overview

    N/A

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