LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K021021
    Device Name
    MODULAR ANGIOGRAPHY SYSTEM AXIOM ARTIS
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS USA, INC.
    Date Cleared
    2002-06-06

    (69 days)

    Product Code
    JAA
    Regulation Number
    892.1650
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K010721,K993037
    Why did this record match?
    Device Name :

    MODULAR ANGIOGRAPHY SYSTEM AXIOM ARTIS

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

    AXIOM Artis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures.

    Procedures that can be performed with the AXIOM Artis family include cardiac angiography, neuroangiography, general angiography, operating room angiography, multipurpose angiography and radiographic/fluoroscopic procedures e.g. Gastro-intestinal imaging, Skeletal imaging etc. AXIOM Artis can also support the acquisition of position triggered imaging for spatial data synthesis.

    The intended use and indications for use of the Modular Angiography System AXIOM Artis with Flat Panel Detector as described in its labeling have not changed from its predicate device AXIOM Artis with the image intensifier.

    Device Description

    The AXIOM Artis Modular Angiography System with Dynamic Flat Panel detector is designed as a set of components that may be combined into different configurations to provide specialized angiography systems. It is basically equal to the AXIOM Artis Modular Angiography System family with all its components. A new Flat Panel detector has been adapted to the system. The detector is comprised of a large area amorphous silicon layer. Flat screen monitors for diagnostic review are optional available.

    AI/ML Overview

    The provided text does not contain information about acceptance criteria or a study proving that the device meets those criteria. Specifically:

    • There is no table of acceptance criteria and reported device performance.
    • There is no mention of sample sizes, data provenance, or details about test sets.
    • There is no information regarding experts, ground truth establishment, or adjudication methods.
    • No multi-reader multi-case (MRMC) study or standalone performance study is described.
    • Details about training sets are also absent.

    The document is a 510(k) summary for a medical device (Modular Angiography System AXIOM Artis with Flat Panel Detector) seeking substantial equivalence to predicate devices, focusing on device description, intended use, and substantial equivalence claims rather than performance studies against specific acceptance criteria.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1