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510(k) Data Aggregation

    K Number
    K965004
    Device Name
    C.A.R.E. VISION FOR THE SOMATOM PLUS 4 CT SCANNER
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS USA, INC.
    Date Cleared
    1997-03-11

    (85 days)

    Product Code
    JAK
    Regulation Number
    892.1750
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    C.A.R.E. VISION FOR THE SOMATOM PLUS 4 CT SCANNER

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

    The C.A.R.E. VISION is intended to be used for instant display of CT images during interventional procedures using CT scanners. Instant image reconstruction of 3-9 images per second allows the physician to watch the placement of an interventional instrument real time.

    Device Description

    The C.A.R.E. VISION option is a new scan mode added to the SOMATOM Plus 4 CT scanner. The option can be installed in the SOMATOM Plus 4 CT as an upgrade kit consisting of hardware, software and firmware. Under C.A.R.E. VISION, three to nine images are reconstructed and displayed per second, effectively simulating a real-time display presentation. More than one C.A.R.E. VISION scans can be set-up and performed one after the other. C.A.R.E. VISION can also be mixed with other scan modes. Switch to SEQUENCE scan mode can be initiated any time during C.A.R.E. VISION thus a particular phase of the operation can be displayed in enhanced image quality.

    AI/ML Overview

    This document does not contain the information required to answer the request regarding acceptance criteria and device performance. The provided text is a 510(k) summary for the C.A.R.E. VISION Option for SOMATOM Plus 4 CT System, primarily focusing on its description, intended use, and substantial equivalence to predicate devices. It does not include:

    • A table of acceptance criteria and reported device performance.
    • Details about a test set, its sample size, or data provenance.
    • Information on experts or ground truth establishment for a test set.
    • Adjudication methods.
    • Multi-reader multi-case (MRMC) comparative effectiveness studies.
    • Standalone algorithm performance.
    • The type of ground truth used.
    • Training set sample size or ground truth establishment for a training set.

    The document discusses the device's ability to reconstruct and display 3-9 images per second, effectively simulating real-time, and its use during interventional procedures to guide instrument placement. However, it does not provide quantitative performance metrics or studies to prove acceptance criteria.

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