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The MAGNETOM system is indicated for use as a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal and oblique cross sectional images, spectroscopic 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/or spectra and the physical parameters derived from the images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis. The MAGNETOM system may also be used for imaging during interventional procedures when performed with MR compatible devices such as in-room displays and MR Safe biopsy needles.

The subject device, MAGNETOM Avanto Fit with software syngo MR XA70A, consists of new and modified software and hardware that is similar to what is currently offered on the predicate device, MAGNETOM Avanto Fit with syngo MR XA50A (K220151). A high-level summary of the new and modified hardware and software is provided below: For MAGNETOM Avanto Fit with syngo MR XA70: Hardware New Hardware: myExam 3D Camera BM Head/Neck 20 Modified Hardware: Sanaflex (cushions for patient positioning) Software New Features and Applications: myExam Autopilot Brain myExam Autopilot Knee 3D Whole Heart HASTE_interactive GRE_PC Open Recon Deep Resolve Gain Fleet Reference Scan Physio logging complex averaging AutoMate Cardiac Ghost Reduction BLADE diffusion Beat Sensor Deep Resolve Sharp Deep Resolve Boost and Deep Resolve Boost (TSE) Deep Resolve Boost HASTE Deep Resolve Boost EPI Diffusion Modified Features and Applications: SPACE improvement (high band) SPACE improvement (incr grad) Brain Assist Eco power mode myExam Angio Advanced Assist (Test Bolus) The subject device, MAGNETOM Skyra Fit with software syngo MR XA70A, consists of new and modified software and hardware that is similar to what is currently offered on the predicate device, MAGNETOM Skyra Fit with syngo MR XA50A (K220589). A high-level summary of the new and modified hardware and software is provided below: For MAGNETOM Skyra Fit with syngo MR XA70: Hardware New Hardware: myExam 3D Camera Modified Hardware: Sanaflex (cushions for patient positioning) Software New Features and Applications: Beat Sensor HASTE_interactive GRE_PC 3D Whole Heart Deep Resolve Gain Open Recon Ghost Reduction Fleet Reference Scan BLADE diffusion HASTE diffusion Physio logging complex averaging Deep Resolve Swift Brain Deep Resolve Sharp Deep Resolve Boost and Deep Resolve Boost (TSE) Deep Resolve Boost HASTE Deep Resolve Boost EPI Diffusion AutoMate Cardiac SVS_EDIT Modified Features and Applications: SPACE improvement (high band) SPACE improvement (incr grad) Brain Assist Eco power mode myExam Angio Advanced Assist (Test Bolus) The subject device, MAGNETOM Sola Fit with software syngo MR XA70A, consists of new and modified software and hardware that is similar to what is currently offered on the predicate device, MAGNETOM Sola Fit with syngo MR XA51A (K221733). A high-level summary of the new and modified hardware and software is provided below: For MAGNETOM Sola Fit with syngo MR XA70: Hardware New Hardware: myExam 3D Camera Modified Hardware: Sanaflex (cushions for patient positioning) Software New Features and Applications: GRE_PC 3D Whole Heart Ghost Reduction Fleet Reference Scan BLADE diffusion Physio logging Open Recon Complex averaging Deep Resolve Sharp Deep Resolve Boost and Deep Resolve Boost (TSE) Deep Resolve Boost HASTE Deep Resolve Boost EPI Diffusion AutoMate Cardiac Implant suite Modified Features and Applications: SPACE improvement (high band) SPACE improvement (incr grad) Brain Assist Eco power mode The subject device, MAGNETOM Viato.Mobile with software syngo MR XA70A, consists of new and modified software and hardware that is similar to what is currently offered on the predicate device, MAGNETOM Viato.Mobile with syngo MR XA51A (K240608). A high-level summary of the new and modified hardware and software is provided below: For MAGNETOM Viato.Mobile with syngo MR XA70: Hardware New Hardware: n.a. Modified Hardware: Sanaflex (cushions for patient positioning) Software New Features and Applications: GRE_PC 3D Whole Heart Ghost Reduction Fleet Reference Scan BLADE diffusion Physio logging Open Recon Complex averaging Deep Resolve Sharp Deep Resolve Boost and Deep Resolve Boost (TSE) Deep Resolve Boost HASTE Deep Resolve Boost EPI Diffusion AutoMate Cardiac Implant suite Modified Features and Applications: SPACE improvement (high band) SPACE improvement (incr grad) Brain Assist Eco power mode Furthermore, the following minor updates and changes were conducted for the subject devices: Low SAR Protocol minor update (for all subject devices but MAGNETOM Skyra Fit): the goal of the SAR adaptive protocols was to be able to perform knee, spine, heart and brain examinations with 50% of the max allowed SAR values in normal mode for head and whole-body SAR. The SAR reduction was achieved by parameter adaptations like Flip angle, TR, RF Pulse Type, Turbo Factor, concatenations. For cardiac clinically accepted alternative imaging contrasts are used (submitted with K232494). Implementation of image sorting prepare for PACS (submitted with K231560). Implementation of improved DICOM color support (submitted with K232494). Needle intervention AddIn was added all subject device (submitted with K232494). Inline Image Filter switchable for users: in the subject device, users have the ability to switch the "Inline image filter" (implicite Filter) on or off. This filter is an image-based filter that can be applied to specific pulse sequence types. The function of the filter remains unchanged from the previous device MAGNETOM Sola with syngo MR XA61A (K232535). SVS_EDIT is newly added for MAGNETOM Skyra Fit, but without any changes (submitted with K203443) Brain Assist received an improvement and is identical to that of snygo MR XA61A (K232535) Open Recon is introduced for all systems. The function of Open Recon remains unchanged from the previous submissions (submitted with K221733). Lock TR and FA in Bold received a minor UI update Implant Suite is newly introduced for MAGNETOM Sola Fit and MAGNETOM Viato.Mobile, but without any changes (submitted with K232535) myExam Autopilot Brain and myExam Autopilot Knee are newly introduced for the subject device MAGNETOM AVANTO Fit and are unchanged from previous submissions (submitted with K221733). myExam Angio Advanced Assist (Test Bolus) received a bug fixing and minimal UI improvements.

syngo Dynamics is a multimodality, vendor agnostic Cardiology image and information system intended for medical image management and processing that provides capabilities relating to the review and digital processing of medical images. syngo Dynamics supports clinicians by providing post image processing functions for image manipulation, and/or quantification that are intended for use in the interpretation and analysis of medical images for disease detection, diagnosis, and/or patient management within the healthcare institution's network. syngo Dynamics is not intended to be used for display or diagnosis of digital mammography images in the U.S.

syngo Dynamics is a software only medical device which is used with common IT hardware. Recommended configurations are defined for the hardware required to run the device, and hardware is not considered as part of the medical device. syngo Dynamics is intended to be used by trained healthcare professionals in a professional healthcare facility to review, edit, and manipulate image data, as well as to generate quantitative data, qualitative data, and diagnostic reports. syngo Dynamics is a digital image display and reporting system with flexible deployment – it can function as a standalone medical device that includes a DICOM Server or as an integrated module within an Electronic Health Record (EHR) System with a DICOM Archive that receives images from digital image acquisition devices such as ultrasound and x-ray angiography machines. There are three deployments: Standalone, EHR/EHS Integrated, and Multi-Modality Cardiovascular (MMCV). MMCV deployment functions as a standalone medical device with capability of natively support 2D and 3D CT and MR image types. The use of syngo Dynamics is focused on cardiac ultrasound (echocardiography), angiography (x-ray), cardiac nuclear medicine (NM), CT and MR studies that cover both adult and pediatric medicine. Also supported is vascular ultrasound and ultrasound in Obstetrics/Gynecology and Maternal Fetal Medicine (fetal echocardiography during pregnancy). syngo Dynamics is based on a client-server architecture. The syngo Dynamics server processes the data from the connected imaging modalities, and stores data and images to a DICOM server and routes them for permanent storage, printing, and review. The client provides the user interface for interactive image viewing, reporting, and processing; and can be installed on network connected workstations. syngo Dynamics provides various semi-automated anatomical visualization tools. syngo Dynamics offers multiple access strategies: A Workplace that provides full functionality for reading and reporting; A Remote Workplace that provides additionally compressed images with access to full fidelity images for reading and reporting; and a browser based WebViewer that provides access to additionally compressed images and reports from compatible devices (including mobile devices). In the United States, monitors (displays) should not be used for diagnosis, unless the monitor (display) has specifically received 510(k) clearance for this purpose.

AI-Rad Companion Organs RT is a post-processing software intended to automatically contour DICOM CT and MR pre-defined structures using deep-learning-based algorithms. Contours that are generated by AI-Rad Companion Organs RT may be used as input for clinical workflows including external beam radiation therapy treatment planning. AI-Rad Companion Organs RT must be used in conjunction with appropriate software such as Treatment Planning Systems and Interactive Contouring applications, to review, edit, and accept contours generated by AI-Rad Companion Organs RT. The outputs of AI-Rad Companion Organs RT are intended to be used by trained medical professionals. The software is not intended to automatically detect or contour lesions.

AI-Rad Companion Organs RT provides automatic segmentation of pre-defined structures such as Organs-at-risk (OAR) from CT or MR medical series, prior to dosimetry planning in radiation therapy. AI-Rad Companion Organs RT is not intended to be used as a standalone diagnostic device and is not a clinical decision-making software. CT or MR series of images serve as input for AI-Rad Companion Organs RT and are acquired as part of a typical scanner acquisition. Once processed by the AI algorithms, generated contours in DICOMRTSTRUCT format are reviewed in a confirmation window, allowing clinical user to confirm or reject the contours before sending to the target system. Optionally, the user may select to directly transfer the contours to a configurable DICOM node (e.g., the Treatment Planning System (TPS), which is the standard location for the planning of radiation therapy). AI-Rad Companion Organs RT must be used in conjunction with appropriate software such as Treatment Planning Systems and Interactive Contouring applications, to review, edit, and accept the automatically generated contours. Then the output of AI-Rad Companion Organs RT must be reviewed and, where necessary, edited with appropriate software before accepting generated contours as input to treatment planning steps. The output of AI-Rad Companion Organs RT is intended to be used by qualified medical professionals, who can perform a complementary manual editing of the contours or add any new contours in the TPS (or any other interactive contouring application supporting DICOM-RT objects) as part of the routine clinical workflow.

Prostate MR AI is a plug-in Radiological Computer Assisted Detection and Diagnosis Software device intended to be used · with a separate hosting application · as a concurrent reading aid to assist radiologists in the interpretation of a prostate MRI examination acquired according to the PI-RADS standard · in adult men (40 years and older) with suspected cancer in treatment naïve prostate glands The plug-in software analyzes non-contrast T2 weighted (T2W) and diffusion weighted image (DWI) series to segment the prostate gland and to provide an automatic detection and segmentation of regions suspicious for cancer. For each suspicious region detected, the algorithm moreover provides a lesion Score, by way of PI-RADS interpretation suggestion. Outputs of the device should be interpreted consistently with ACR recommendations using all available MR data (e.g., dynamic contrast enhanced images [if available]). Patient management decisions should not be made solely based on analysis by the Prostate MR AI algorithm.

This premarket notification addresses the Siemens Healthineers Prostate MR AI (VA10A) Radiological Computer Assisted Detection and Diagnosis Software (CADe/CADx). Prostate MR AI is a Computer Assisted Detection and Diagnosis algorithm designed to plug into a hosting workflow that assists radiologists in the detection of suspicious lesions and their classification. It is used as a concurrent reading aid to assist radiologists in the interpretation of a prostate MRI examination acquired according to the PI-RADS standard. The automatic lesion detection requires transversal T2W and DWI series as inputs. The device automatically exports a list of detected prostate regions that are suspicious for cancer (each list entry consists of contours and a classification by Score and Level of Suspicion (LoS)), a computed suspicion map, and a per-case LoS. The results of the Prostate MR AI plug-in (with the case-level LoS, lesion center points, lesion diameters, lesion ADC median, lesion 10th percentile, suspicion map, and non-PZ segmentation considered optional) are to be shown in a hosting application that allows the radiologist to view the original case, as well as confirm, reject, or edit lesion candidates with their contours and Scores as generated by the Prostate MR AI plug-in. Moreover, the radiologist can add lesions with contours and PI-RADS scores and finalize the case. In addition, the outputs include an automatically computed prostate segmentation, as well as sub-segmentations of the peripheral zone and the rest of the prostate (non-PZ). The algorithm will augment the prostate workflow of currently cleared syngo.MR General Engine if activated via a separate license on the General Engine.

MyAblation Guide is a software application for image processing, 2D/3D visualization, and comparison of medical images imported from multiple imaging modalities. The software is controlled by the end user interface on a workstation with DICOM connectivity or as an integrated version on a Siemens CT scanner workstation. The application is used to assist in the preparation and performance of ablative procedures, including of ablation targets, virtual ablation probe placement and contouring of ablated areas, as well as supporting the User in their assessment of the treatment. The application can only be used by trained Users. The software is not intended for diagnosis and is not intended to predict ablation volumes or predict ablation success.

myAblation Guide is a software medical device that is used in the context of percutaneous ablative procedures with straight instruments. It is used by clinical professionals in a hospital premise; it can be either deployed on compatible CT scanners or a computer workstation. The application is operated by medical professionals such as Interventional Radiologists and medical technologists with current license and/or certification as required by regional authority. myAblation Guide allows operating functions in an arbitrary sequence. In addition, it includes a structured sequence of steps for ease of utility. The application supports anatomical datasets from CT, MR, CBCT, as well as PET/CT. The application includes means and functionalities to support in: · Multimodality viewing and contouring of anatomical, and multi-parametric images such as CT, CBCT, PET/CT, MRI · Multiplanar reconstruction (MPR) thin/thick, minimum intensity projection (MIP), volume rendering technique (VRT) · Freehand and semi-automatic contouring of regions-of-interest on any orientation including oblique - Manual and semi-automatic registration using rigid and deformable registration - · Expansion of created contour structures to visualize a safety margin · Functionality to support the user in creating virtual ablation needle paths and associated virtual ablation zones derived from manufacturer data - · Export of virtual needle paths in the Dicom SSO format - · Supports the user in comparing, contouring, and ablation needle planning based on datasets acquired with different imaging modalities - Supports multimodality image fusion - · Supports user's procedure flow via a task stepper Thermal ablation cannot be triggered from myAblation Guide.

Syngo Carbon Enterprise Access is indicated for display and rendering of medical data within healthcare institutions.

Syngo Carbon Enterprise Access is a software only medical device which is intended to be installed on recommended common IT Hardware. The hardware is not seen as part of the medical device. Syngo Carbon Enterprise Access is intended to be used in clinical image and result distribution for diagnostic purposes by trained medical professionals and provides standardized generic interfaces to connect to medical devices without controlling or altering their functions. Syngo Carbon Enterprise Access provides an enterprise-wide web application for viewing DICOM, non-DICOM, multimedia data and clinical documents to facilitate image and result distribution.

AI-Rad Companion (Pulmonary) is image processing software that provides quantitative and qualitative analysis from previously acquired Computed Tomography DICOM images to support radiologists and physicians from specialty care and general practice in the evaluation and assessment of disease of the lungs. It provides the following functionality: - Segmentation and measurements of complete lung and lung lobes - · Identification of areas with lower Hounsfield values in comparison to a predefined threshold for complete lung and lung lobes - · Providing an interface to external Medical Device syngo.CT Lung CAD - · Segmentation and measurements of solid and sub-solid lung nodules - Dedication of found lung nodules to corresponding lung lobe - Correlation of segmented lung nodules of current scan with known priors and quantitative assessment of changes of the correlated data. - Identification of areas with elevated Hounsfield values, where areas with elevated versus high opacities are distinquished. The software has been validated for data from Siemens Healthineers (filtered backprojection and iterative reconstruction), GE Healthcare (filtered backprojection reconstruction), and Philips (filtered backprojection reconstruction). Only DICOM images of adult patients are considered to be valid input.

The subject device AI-Rad Companion (Pulmonary) is an image processing software that utilizes machine learning and deep learning algorithms to provide quantitative and qualitative analysis from previously acquired Computed Tomography DICOM images to support qualified clinicians in the evaluation and assessment of disease of the thorax. AI-Rad Companion (Pulmonary) builds on platform functionality provided by the AI-Rad Companion Engine and cloud/edge functionality provided by the Siemens Healthineers teamplay digital platform. AI-Rad Companion (Pulmonary) is an adjunct tool and does not replace the role of a qualified medical professional. AI-Rad Companion (Pulmonary) is also not designed to detect the presence of radiographic findings other than the prespecified list. Qualified medical professionals should review original images for all suspected pathologies. AI-Rad Companion (Pulmonary) offers: - Segmentation of lungs, ● - Segmentation of lung lobes. - Parenchyma evaluation, ● - Parenchyma ranges, - Pulmonary density, - Visualization of segmentation and parenchyma results, - Interface to LungCAD, - Lesion segmentation, ● - Visualization of lesion segmentation results, ● - Lesion follow-up AI-Rad Companion (Pulmonary) requires images of patients of 22 years and older. AI-Rad Companion (Pulmonary) SW version VA40 is an enhancement to the previously cleared device AI-Rad Companion (Pulmonary) (K213713) that utilizes machine and deep learning algorithms to provide quantitative and qualitative analysis to computed tomography DICOM images to support qualified clinicians in the evaluation and assessment of disease of the thorax. As an update to the previously cleared device, the following modifications have been made: - Sub-solid Lung Nodule Segmentation ● This feature provides the ability to segment and measure all subtypes of lesions including solid and sub-solid lesions. - . Modified Indications for Use Statement The indications for use statement was updated to include descriptive text for sub-solid lung nodule addition. - Updated Subject Device Claims List The claims list was updated to reflect the new device functionality - . Updated Limitations for Use Additional limitations for use has been added to the subject device.

syngo Virtual Cockpit is a software application intended for remote operation, assistance, review, monitoring, and standardization of medical imaging devices. It is a vendor neutral solution allowing read-only or full access control to connected devices. syngo Virtual Cockpit is also intended for training of medical personnel working on the medical imaging devices.

syngo Virtual Cockpit (sVC) is a software solution for geographically distant technologist or radiologists to remotely assist with operating imaging equipment and radiotherapeutic devices. sVC provides a private, secure communication platform for real-time image visualization and crossorganizational collaboration between healthcare professionals across multiple sites. sVC enables remote access to modality consoles and enhances communication capabilities between healthcare professionals across different locations. It is vendor-neutral and applicable to existing multimodalities in a healthcare network, a solution that allows healthcare professionals to share expertise and increase productivity, even when they are not physically present in the same location. sVC is based on a client server architecture, with sVC server as the backbone and 3 different variants of client, based on the user roles, Modality client & Physician client. Modality client as two flavors one windows based client and a web client which can be hosted in a web browser. Steering client establishes remote connection to Modality console / Modality acquisition workplace through KVM (Keyboard, Video and Mouse) switch or Siemens proprietary accessing tool, syngo Expert-i. Steering client can establish connections to more than one (up to 3) Modality console applications. Physician client is the third client for Physician that can be contacted either by Steering technologist or by Modality technologist for assistance regarding scanning in more complex cases, or the Physician can provide expert radiologist knowledge. The connection is possible in full control or read-only mode. The full-control accessibility to CT scanners is limited to the software associated with the modality workplace and is not applicable to the physical switches controlling the equipment operation. The connection to radiotherapeutic equipment is limited to be read-only. In addition to enabling remote access and control of the modality scanners, sVC also supports common communication methods including live videos at the modality site, audio calls and text chats among users.

Syngo Carbon Clinicals is intended to provide advanced visualization tools to prepare and process the medical image for evaluation, manipulation and communication of clinical data that was acquired by the medical imaging modalities (for example, CT, MR, etc.) The software package is designed to support technicians and physicians in qualitative and quantitative measurements and in the analysis of clinical data that was acquired by medical imaging modalities. An interface shall enable the connection between the Syngo Carbon Clinicals software package and the interconnected software solution for viewing, manipulation, communication, and storage of medical images.

Syngo Carbon Clinicals is a software only Medical Device, which provides dedicated advanced imaging tools for diagnostic reading. These tools can be called up using standard interfaces any native/syngo based viewing applications (hosting applications) that is part of the SYNGO medical device portfolio. These tools help prepare and process the medical image for evaluation, manipulation and communication of clinical data that was acquired by medical imaging modalities (e.g., MR, CT etc.) Deployment Scenario: Syngo Carbon Clinicals is a plug-in that can be added to any SYNGO based hosting applications (for example: Syngo Carbon Space, syngo.via etc...). The hosting application (native/syngo Platform-based software) is not described within this 510k submission. The hosting device decides which tools are used from Syngo Carbon Clinicals. The hosting device does not need to host all tools from the Syngo Carbon Clinicals, a desired subset of the provided tools can be used. The same can be enabled or disabled thru licenses.

syngo.CT Lung CAD device is a computer-aided detection (CAD) tool designed to assist radiologists in the detection of solid and subsolid pulmonary nodules during review of multi-detector computed tomography (MDCT) from multivendor examinations of the chest. The software is an adjunctive tool to alert the radiologist to regions of interest (ROI) that may be otherwise overlooked. The syngo.CT Lung CAD device may be used as a concurrent first reader followed by a full review of the case by the radiologist or as second reader after the radiologist has completed his/her initial read. The syngo.CT Lung CAD device may also be used in "solid-only" mode, where potential (or suspected) sub-solid and/or fully calcified CAD findings are filtered out. The software device is an algorithm which does not have its own user interface component for displaying of CAD marks. The Hosting Application incorporating syngo. CT Lung CAD is responsible for implementing a user interface.

Siemens Healthcare GmbH intends to market the syngo.CT Lung CAD which is a medical device that is designed to perform CAD processing in thoracic CT examinations for the detection of solid pulmonary nodules (between 3.0 mm and 30.0mm) and subsolid nodules (between 5.0 mm and 30.0mm) in average diameter. The device processes images acquired with multi-detector CT scanners with 16 or more detector rows recommended. The syngo.CT Lung CAD device supports the full range of nodule locations (central, peripheral) and contours (round, irregular). The syngo.CT Lung CAD sends a list of nodule candidate locations to a visualization application, such as syngo MM Oncology, or a visualization rendering component, which generates output images series with the CAD marks superimposed on the input thoracic CT images to enable the radiologist's review. syngo MM Oncology (FDA clearanceK211459 and subsequent versions ) is deployed on the syngo.via platform (FDA clearance k191040 and subsequent versions), which provides a common framework for various other applications implementing specific clinical workflows (but are not part of this clearance) to display the CAD marks. The syngo.CT Lung CAD device may be used either as a concurrent first reader, followed by a review of the case, or as a second reader only after the initial read is completed