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510(k) Data Aggregation

    K Number
    K050476
    Device Name
    CORDLESS COIL
    Manufacturer
    SIEMENS MEDICAL SOLUTION, INC. USA
    Date Cleared
    2005-03-25

    (29 days)

    Product Code
    MOS, LNH
    Regulation Number
    892.1000
    Why did this record match?
    Applicant Name (Manufacturer) :

    SIEMENS MEDICAL SOLUTION, INC. USA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Cordless coil is a receive type surface coil. When used in the MAGNETOM Concerto and C! MR systems, it is indicated for use as a when about in alle interese to produce transverse, sagittal, coronal and oblique images of internal structures of the brain and body surface. The images produced reflect the spatial distribution of protons exhibiting magnetic resonance. Spectra allow the molecules containing the nucleus under investigation to be distinguished. The NMR properties that determine the image and spectra appearance are spin density, spin-lattice relaxation time (T1), and spin-spin echo time (T2) of the corresponding nucleus. When interpreted by a trained physician, these images and spectra provide information that can be useful in making diagnoses.
    Device Description
    The Cordless Coil. It is a set consisting of two coils. The coupling loop is connected with a cable and one receive coil is inductively coupled to the other.
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    K Number
    K050297
    Device Name
    SOMATOM EMOTION 16
    Manufacturer
    SIEMENS MEDICAL SOLUTION, INC. USA
    Date Cleared
    2005-03-01

    (22 days)

    Product Code
    JAK
    Regulation Number
    892.1750
    Why did this record match?
    Applicant Name (Manufacturer) :

    SIEMENS MEDICAL SOLUTION, INC. USA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SOMATOM Emotion 16 is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angels or spiral planes* taken at different angles. (*spiral planes: the axial planes resulted from the continuous rotation of detectors and x-ray tube, and the simultaneous translation of the patient. )
    Device Description
    The Siemens SOMATOM Emotion 16 system is a 16 slice, whole body X-ray computed tomography systems, which features a continuously rotating tube-detector system and functions according to the fan beam principle. The software is syngo-based Somaris/5 software version VB28, which is a command-based program used for patient management, data management, X-ray scan control, image reconstruction, and image archive/evaluation.
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    K Number
    K042229
    Device Name
    SOMATOM RADIATION TREATMENT PLANNING (RTP) PACKAGE
    Manufacturer
    SIEMENS MEDICAL SOLUTION, INC. USA
    Date Cleared
    2004-09-01

    (15 days)

    Product Code
    JAK
    Regulation Number
    892.1750
    Why did this record match?
    Applicant Name (Manufacturer) :

    SIEMENS MEDICAL SOLUTION, INC. USA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The use of standard CT scanners in Radiation Treatment Planning environments requires a higher geometric accuracy of anatomical data. For the Siemens SOMATOM Emotion CT systems, a dedicated RTP package (including both hardware and software components) will be offered and provides the following features: improved gantry tilt accuracy, reduced table top deflection, externally adjustable gantry laserlights, increased tube positioning accuracy, simplified horizontal positioning of the table, optimized field coverage using extended Field of View. Radiation Treatment Planning (RTP) Package will be used to prepare geometric and anatomical data, which may assist the physician with proposed external beam radiotherapy treatment planning.
    Device Description
    A dedicated RTP package for the SOMATOM Emotion CT Systems includes both hardware and software components and further improves the geometric accuracy of anatomical data. The RTP package will provide the following: Improved gantry tilt accuracy, Reduced table top deflection, Externally adjustable gantry laserlights, Increased x-ray tube positioning accuracy, Simplified horizontal positioning of the table, Optimized field coverage using extended Field of View (FOV).
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