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510(k) Data Aggregation

    K Number
    K133646
    Device Name
    ADMIRE
    Manufacturer
    SIEMENS MEDICAL SYSTEMS, INC.
    Date Cleared
    2014-06-20

    (205 days)

    Product Code
    JAK, 90J
    Regulation Number
    892.1750
    Why did this record match?
    Applicant Name (Manufacturer) :

    SIEMENS MEDICAL SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ADMIRE is a CT reconstruction software. The end user can choose to apply either ADMIRE or the weighted filter backprojection (WFBP) to the acquired raw data. Depending on the clinical task, patient size, anatomical location, and clinical practice, the use of ADMIRE can help to reduce radiation dose while maintaining pixel noise, low contrast detectability and high contrast resolution. Phantom measurements showed that high contrast resolution and pixel noise are equivalent between full dose WFBP images and reduced dose ADMIRE images. Additionally, ADMIRE can reduce spiral artifacts by using iterations going back and forth between image space and raw data space. Images reconstructed with ADMIRE are not intended to be evaluated with syngo Osteo CT or syngo Calcium Scoring.
    Device Description
    Siemens ADMIRE is an extension of the previously cleared Sinogram Affirmed Iterative Reconstruction (SAFIRE) reconstruction algorithm. ADMIRE is a software option for CT operating systems that provides an improved image quality or reciprocally can allow the physician to acquire scans with reduced radiation dose without reduction of image quality compared to today's standard. ADMIRE is designed to improved reconstructed image quality through the integration of additional processing steps in image reconstruction. These additional steps result in the following improvements in image quality: - . Higher pixel noise reduction - A noise texture closer to filtered back projection (FBP) . - . Improved resolution for high contrast edges
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    K Number
    K130901
    Device Name
    SOMATOM DEFINITION AS OPEN
    Manufacturer
    SIEMENS MEDICAL SYSTEMS, INC.
    Date Cleared
    2014-01-02

    (276 days)

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

    SIEMENS MEDICAL SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Siemens SOMATOM Definition AS Open systems are 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 angles 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 Definition AS Open is a whole body X-ray Computed Tomography System. The SOMATOM Definition AS Open produces CT images in DICOM format, which can be used by post-processing applications commercially distributed by Siemens and other vendors. The system software is a command-based program used for patient management, data management, X-ray scan control, image reconstruction, and image archive/evaluation. The new version of system software, syngo® CT 2013B (SOMARIS/7 VA46A), supports the following features: - MARIS (Metal Artifact Reduction in Image Space) A image . reconstruction mode designed to reduce image artifacts caused by metal - HD FoV Pro (HD FoV 2.0) Designed to enable a more reliable . visualization of the skin line of human body parts located outside of the standard field of view - t-MIP -- Image manipulation method for arithmetic operations which allows . the calculation of temporal Maximum or Minimum Intensity Projection (MIP) images from a set of series.
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    K Number
    K123540
    Device Name
    SYNGO CT PULMO 3D
    Manufacturer
    SIEMENS MEDICAL SYSTEMS, INC.
    Date Cleared
    2013-08-29

    (283 days)

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

    SIEMENS MEDICAL SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    syngo.CT Pulmo 3D is an image analysis software for CT volume data sets. It analyses the lunq, either completely or in parts, identifying areas with lower or higher Hounsfield values in comparison to a predefined threshold. These areas are evaluated using statistical methods such as histograms and percentiles. Using syngo.CT Pulmo 3D, you can examine the lung parenchyma and the airways of the lung. The following evaluation tools are provided: - Computation of lung volumes . - Display of statistics related to the lung . - Setting of markers . - Airway measurements . syngo.CT Pulmo 3D facilitates the reporting by using of appropriate reporting tools, for example, key image creation. You can use syngo.CT Pulmo 3D to create a DiCOM Structured Report.
    Device Description
    syngo.CT Pulmo 3D allows the evaluation of lung tissue and airways. In contrast to lung function tests, CT evaluations can show the effect of a disease on the parenchyma and the airways. The lungs as well as the airways are segmented in the preprocessing, and divisions of the lungs like thirds, core/peel, and lung lobes are calculated.
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    K Number
    K123541
    Device Name
    SYNGO.CT NEURO PERFUSION
    Manufacturer
    SIEMENS MEDICAL SYSTEMS, INC.
    Date Cleared
    2013-04-02

    (134 days)

    Product Code
    JAK, 90J
    Regulation Number
    892.1750
    Why did this record match?
    Applicant Name (Manufacturer) :

    SIEMENS MEDICAL SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The syngo.CT Neuro Perfusion software package is designed to evaluate areas of brain perfusion. The software processes images or volumes that were reconstructed from continuously acquired CT data after the injection of contrast media. It generates the following result volumes: - Cerebral blood flow (CBF) - Cerebral blood volume (CBV) - Local bolus timing (time to start (TTS), time to peak (TTP), time to drain (TTD)) - Mean transit time (MTT) - Transit time to the center of the IRF (TMax) - Flow extraction product (permeability) - Temporal MIP - Temporal Average - Baseline Volume - Modified dynamic input data The software also allows the calculation of mirrored regions or volumes of interest and the visual inspection of time attenuation curves. One clinical application is to visualize the apparent blood perfusion and the parameter mismatch in brain tissue affected by acute stroke. Areas of decreased perfusion appear as areas of changed signal intensity: - Lower signal intensity for CBF and CBV - Higher signal intensity for TTP, TTD, MTT, and TMax A second application is to visualize blood brain barrier disturbances by modeling extra-vascular leakage of blood into the interstitial space. This additional capability may improve the differential diagnosis of brain tumors and be helpful in therapy monitoring.
    Device Description
    The syngo. CT Neuro Perfusion software allows the quantitative evaluation of dynamic CT data of the brain acquired during the injection of a compact bolus of iodinated contrast material. It mainly aids in the early differential diagnosis of acute ischemic stroke. Blood-brain-barrier (BBB) imaging also supports the diagnostic assessment of brain tumors. By providing images of e.g. cerebral blood flow (CBF), cerebral blood volume (CBV), time to peak (TTP), and Mean Transit Time (MTT) from one set of dynamic CT images or volumes, syngo.CT Neuro Perfusion allows a quick and reliable assessment of the type and extent of cerebral perfusion disturbances. The underlying approaches have been validated in extensive clinical studies and have been in routine clinical use for more than 10 vears. The current syngo.CT Neuro Perfusion implementation allows simultaneous multi-slice processing and supports the workflow requirements in a stroke workflow. The availability of flow extraction product imaging extends the option to the diagnosis of brain tumors.
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    K Number
    K122909
    Device Name
    SYNGO SINGLE SOURCE DUAL ENGERY
    Manufacturer
    SIEMENS MEDICAL SYSTEMS, INC.
    Date Cleared
    2012-12-27

    (97 days)

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

    SIEMENS MEDICAL SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    syngo® Single Source Dual Energy is designed to operate with CT images taken at the same anatomical region of a patient using two different kV levels. The differences in the energy dependence of the attenuation coefficient of the different materials provide information about the chemical composition of body materials. The images are combined to visualize and analyze information about anatomical and pathological structures. The functionality of the syngo® Single Source Dual Energy applications are as follows: - Gout Evaluation . - Monoenergetic .
    Device Description
    Dual Energy CT can be used to obtain intensity measurements with two different spectra and thus provides additional information when compared to single energy. This additional information is analyzed in the post processing application syngo Single Source Dual Energy and can be used to improve the visualization of various materials in the human body. After loading the reconstructed images corresponding to the two subsequent scans with different X-ray spectra into syngo® Single Source Dual Energy, the images are first registered to compensate for motion effects. They are then displayed using linear blending with selectable mixing ratio and color scale ("General Viewing"). Multiplanar reformations (MPR) of the volume are shown in 3 image segments, which are initialized as sagittal, coronal and axial view. After arriving at an initial diagnosis on the basis of the CT-images, the user can choose between application classes Monoenergetic or Gout Evaluation. These application classes are designed for specific clinical tasks, so that algorithms, additional tool buttons, the use of colored overlay images and image representation (for example MPR or maximum intensity projection) are optimized correspondingly. For Gout Evaluation a fourth image segment is used for volume rendering techniques (VRT). If is possible to adjust Gout Evaluation by using a configuration dialog. Special tools are available to remove the table or perform manual punching.
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    K Number
    K122471
    Device Name
    SOMATOM DEFINITION
    Manufacturer
    SIEMENS MEDICAL SYSTEMS, INC.
    Date Cleared
    2012-09-11

    (28 days)

    Product Code
    JAK, 90J
    Regulation Number
    892.1750
    Why did this record match?
    Applicant Name (Manufacturer) :

    SIEMENS MEDICAL SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SOMATOM P45 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 angles or spiral planes* taken at different angles. (*spiral planes: the axial planes resulting from the continuous rotation of detectors and x-ray tube, and the simultaneous translation of the patient.)
    Device Description
    The Siemens SOMATOM P45 is a whole body X-ray Computed Tomography System, which features two continuously rotating tube-detector systems and functions according to the fan beam principle. The SOMATOM P45 produces CT images in DICOM format, which can be used by postprocessing applications commercially distributed by Siemens and other vendors. The system software is a command-based program used for patient management, data management, X-ray scan control, image reconstruction, and image archive/evaluation. The new version of system software, SOMARIS/7 VA44, supports a Windows 7 operating system, additional scanning and evaluation techniques CARE (Combined Application to Reduce Exposure) and FAST (Fully Assisted Scanner Technology), and single click 3D reconstruction of Dual Energy Scans. The computer system delivered with the CT scanner is able to run the post processing applications optionally.
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    K Number
    K120579
    Device Name
    SOMATOM DEFINITION EDGE
    Manufacturer
    SIEMENS MEDICAL SYSTEMS, INC.
    Date Cleared
    2012-05-23

    (86 days)

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

    SIEMENS MEDICAL SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K121072
    Device Name
    SOMATOM DEFINITION FLASH
    Manufacturer
    SIEMENS MEDICAL SYSTEMS, INC.
    Date Cleared
    2012-05-08

    (29 days)

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

    SIEMENS MEDICAL SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Siemens SOMATOM Definition Flash system 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 angles or spiral planes* taken at different angles. In addition the SOMATOM Definition Flash is able to produce additional image planes and analysis results by executing optional post processing features, which operate on DICOM images. The images and results delivered by the system can be used by a trained physician as an aid in diagnosis. (*spiral planes: the axial planes resulting from the continuous rotation of detectors and x-ray tube, and the simultaneous translation of the patient.)
    Device Description
    The Siemens SOMATOM Definition Flash is a Computed Tomography X- ray System, which features two continuously rotating tube-detector systems and functions according to the fan beam principle. The SOMATOM Definition Flash produces CT images in DICOM format, which can be used by post-processing applications commercially distributed by Siemens and other vendors. The system software is a command-based program used for patient management. data management, X-ray scan control, image reconstruction, and image archive/evaluation. The new version of system software, SOMARIS/7 VA44, allows the reconstruction of images with a slice thickness of 0.5mm for SOMATOM Definition Flash systems equipped with Stellar Detector. The computer system delivered with the CT scanner is able to run the post processing applications optionally. The Stellar Detector will be offered as an optional upgrade to the cleared SOMATOM Definition Flash CT systems.
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    K Number
    K113342
    Device Name
    SOMATOM DEFINITION FLASH
    Manufacturer
    SIEMENS MEDICAL SYSTEMS, INC.
    Date Cleared
    2011-12-29

    (45 days)

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

    SIEMENS MEDICAL SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Siemens SOMATOM Definition Flash (with Stellar Detector) system 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 angles or spiral planes* taken at different angles. In addition the SOMATOM Definition Flash (with Stellar Detector) is able to produce additional image planes and analysis results by executing optional post processing features, which operate on DICOM images. The images and results delivered by the system can be used by a trained physician as an aid in diagnosis. (*spiral planes: the axial planes resulting from the continuous rotation of detectors and x-ray tube, and the simultaneous translation of the patient.)
    Device Description
    The Siemens SOMATOM Definition Flash (with Stellar Detector) is a Computed Tomography X- ray System, which features two continuously rotating tube-detector systems and functions according to the fan beam principle. The system software is a command-based program used for patient management, data management, X-ray scan control, image reconstruction, and image archive/evaluation. The SOMATOM Definition Flash (with Stellar Detector) produces CT images in DICOM format, which can be used by post-processing applications commercially distributed by Siemens and other vendors. The computer system delivered with the CT scanner is able to run such post processing applications optionally.
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    K Number
    K052216
    Device Name
    SOMATOM DEFINITION
    Manufacturer
    SIEMENS MEDICAL SYSTEMS, INC.
    Date Cleared
    2005-09-08

    (36 days)

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

    SIEMENS MEDICAL SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SOMATOM P45 is intended to produce cross-sectional images of the body by The SOMA TOM 145 13 medical vary ... at different angels or spiral planes* taken at different angles. (*spiral planes: the axial planes resulting from the continuous rotation of detectors and xray tube, and the simultaneous translation of the patient.)
    Device Description
    The Siemens SOMATOM P45 is a whole body X-ray computed tomography system, which I he Slement SOMATON 1-19-15 a wills and functions and functions according to the fan assisted teatures two continuously routing is a command-based program used for paint management, data management, X-ray scan control, image reconstruction, and image archive/evaluation.
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