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510(k) Data Aggregation

    K Number
    K060631
    Device Name
    BIOGRAPH 64 AND BIOGRAPH 40
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS USA, INC.
    Date Cleared
    2006-03-17

    (8 days)

    Product Code
    KPS
    Regulation Number
    892.1200
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K060060,K050509,K040665
    Why did this record match?
    Reference Devices :

    K060060, K050509, K040665

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Siemens PET/CT scanners are combined Positron Emission Tomography (PET) and X-Ray Computed Tomography (CT) scanners. The Biograph 64 and 40 are intended to be utilized by appropriately trained health care professionals to:

    • Image and measure the distribution of injected positron emitting radiopharmaceuticals in humans for the purpose of determining various metabolic (molecular) and physiologic functions within the human body; and
    • Produce cross-sectional images of the body by computer reconstruction of X-Ray transmission data from either the same axial plan taken at different angles or spiral planes taken at different angles.
      The Biograph 64 and 40 PET/CTs provide registration and fusion of highresolution metabolic and anatomic information. The PET component utilizes the CT for fast attenuation correction maps for PET studies and precise anatomical reference for fused PET and CT images. Additionally, the system maintains independent functionality of the PET and CT devices, allowing for single modality CT and / or PET diagnostic imaging.
    Device Description

    The Biograph 64 and Biograph 40 are combined Positron Emission Tomography and X-Ray Computed Tomography scanners. These systems are designed for whole-body oncology, neurology and cardiology examinations. The Biograph systems provide registration and fusion of high-resolution metabolic and anatomic information from the two major components of each system, the Siemens LSO HiRez PET scanner and the Siemens Somatom Sensation 64 or 40 CT.
    The combined PET/CT scanner is intended for use as a clinical, whole-body machine with high-end spiral CT and PET performance. The CT component provides attenuation correction for PET studies as well as precise anatomical reference through fused PET and CT images. In addition, the PET / CT system maintains independent functionality of the PET and CT scanning systems, allowing for most standard stand-alone CT and PET clinical diagnostic protocols to be available as well.

    AI/ML Overview

    The provided text is a 510(k) summary for the Biograph 64 and Biograph 40 PET/CT systems. It describes the devices, their indications for use, and claims substantial equivalence to previously cleared devices.

    Based on the content, this document does not contain information about specific acceptance criteria, a study proving the device meets those criteria, or details regarding sample sizes, expert involvement, adjudication methods, or ground truth establishment. The document is primarily a regulatory submission for premarket notification, focusing on equivalence to existing devices rather than a detailed performance study against defined acceptance criteria.

    Therefore, I cannot provide a table of acceptance criteria and reported device performance from this document, nor can I answer the specific questions about standalone performance, MRMC studies, sample sizes, or ground truth establishment for a performance study. This type of information is typically found in detailed validation reports, not in a 510(k) summary.

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