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Your MAGNETOM system is indicated for use as a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal and oblique cross sectional images and/or spectra, and that displays the internal structure and/or function of the head, body, or extremities. Other physical parameters derived from the images and/or spectra may also be produced. Depending on the region of interest, contrast agents may be used. These images and the physical parameters derived from the images and/or spectra, when interpreted by a trained physician, yield information that may assist in diagnosis. Your MAGNETOM system may also be used for imaging during interventional procedures when performed with MR compatible devices such as in-room display and MR-Safe biopsy needles. Software syngo MR E11E with Ischemic Heart Disease (HD) Workflow, when used with a gadolinium-based contrast agent (GBCA) approved for cardiac MRI (CMRI) is indicated for the acquisition and display of images of myocardial perfusion (stress, rest) and late gadolinium enhancement (LGE) during post-contrast CMRI examination in patients with known or suspected coronary artery disease (CAD).

MAGNETOM Aera and MAGNETOM Skyra with Software syngo MR E11E with IHD Workflow are the subject devices. The Software syngo MR E11E with IHD Workflow, when used with a gadolinium-based contrast agent (GBCA) approved for CMRI, extends the capability of the cleared Cardiac Dot Engine (K121434) for post-contrast CMRI exams for patients with known or suspected coronary artery disease (CAD). Software syngo MR E11E with IHD Workflow is available for MAGNETOM Aera and MAGNETOM Skyra excluding the 24-channel configuration. A. The cleared Cardiac Dot Engine (syngo MR D13A, K121434) helps acquisition and display of cardiac morphology and function (noncontrast CMRI). A comprehensive post-contrast CMRI exam includes stress/rest perfusion and late gadolinium enhanced (LGE) imaging. To accomplish post-contrast CMRI imaging, basic morphologic / functional imaging (noncontrast CMRI) is required. Therefore, the cleared Cardiac Dot Engine (syngo MR D13A, K121434) is a pre-requisite to the subject devices. B. The Cardiac Dot Engine together with the IHD Workflow and a GBCA approved for post-contrast CMRI provides for a complete (pre- and post-contrast) examination. The primary predicate devices are modified to include a new Dot Workflow named "Ischemic Heart Disease" (IHD) Workflow for a post-contrast CMRI exam using pulse sequences already cleared in the USA (syngo MR D13A, K121434). A new Dot Workflow "Ischemic Heart Disease" is added in Cardiac Dot Engine dropdown list, under the region "heart". This Dot Workflow includes the following: six new post-contrast CMRI measurement protocols and one workflow step: New Measurement protocols: 1. DynamicTest (test protocol for perfusion imaging without contrast agent) 2. DynamicStress (protocol for perfusion imaging under stress conditions) 3. DynamicRest (protocol for perfusion imaging under rest conditions) 4. DE overview (protocol for delayed enhancement (DE) or LGE with low spatial resolution as an overview) 5. DE_seg_high-res_LAX (protocol for DE or LGE with high spatial resolution in long axis view) 6. DE seg high-res SAX (protocol for DE or LGE with high spatial resolution in short axis view) New workflow step: 1. Inject contrast agent. This step prompts the user to start the contrast agent injection for post-contrast CMRI exams.

The syngo Application Software is a medical software for real-time viewing, image manipulation, communication, and storage of medical images and data on exchange media. It is used for diagnostic image viewing and post processing and for viewing and post processing during interventional procedures. The syngo Application Software can be deployed on independent hardware such as a stand-alone diagnostic review, post-processing, and reporting workstation. It can also be configured within a network to send and receive DICOM data. Furthermore, the syngo Application Software can be deployed on systems Angiography system family. It provides image guided solutions in the operating room, for image guided surgery, by Image Fusion and by navigation systems, image guided solutions in interventional cardiology and image guided solutions for interventional oncology, interventional radiology, and interventional neuroradiology. The syngo Application Software can also be combined with fluoroscopy systems or Radiographic systems. The syngo Application Software can be configured with a variety of syngo or Windows-based software options, which are intended to assist the physician in diagnosis, treatment control. It includes commercially available post-processing techniques and OEM options. Procedures that can be performed include: minimally invasive surgical procedures and minimally invasive turnor treatment.

The "syngo Application Software" is medical diagnostic software for real-time viewing, diagnostic review, post-processing, image manipulation, optimization, communication, reporting and storage of medical images and data on exchange media. It provides image-quided solutions in the operating room, for imageguided surgery, by Image Fusion and by navigation systems, image-guided solutions in interventional cardiology and electrophysiology and image-guided solutions for interventional oncology, interventional radiology, and interventional neuroradiology. It can be deployed with a variety of syngo or Windows-based software options, which are intended to assist the physician in the evaluation of digital radiographic examinations, including diagnosis and/or treatment planning. Siemens "syngo Application Software" (VD20B) is designed to work with digital radiographic, fluoroscopic, interventional and angiographic systems. The software platform with common software architecture, syngo application packages, and basic services is the same as used with the "syngo Application Software" (VD20B) K170747 with exception of the added software options "Instant Fusion" and "Common Patient Registration". The new optional software features are only possible in an angiography (ARTIS Family) and CT (SOMATOM CT Sliding Gantry) systems configuration known as "nexaris Angio-CT". "Instant Fusion" and "Common Patient Registration" is the subject of this submission. These features seamlessly integrate Angio and CT together and facilitate combined use. The "Instant Fusion" is an overlay of CT datasets to the Angiography image. The overlay is a position based registration of the CT gantry. The "Common Patient Registration" is the patient data transfer from "syngo Application Software" to the CT system using a communication interface.