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The Sensis Vibe Hemo (VD15B) and Sensis Vibe Combo (VD15B) recording systems are intended to be used as a diagnostic and administrative tool supporting hemodynamic cardiac catheterizations and/or electrophysiology studies, for cardiac as well as interventional radiology and surgical studies. The system is equipped with modules, enabling various configurations ranging from a standalone acquisition unit with limited administrative functionality to multiunit installations with a common database and satellite workstations accessing the administrative tools. The device is intended to be used on either or both of the following populations: 1. Adult and pediatric populations requiring electrophysiology examinations, typically when the patient is suffering from cardiac arrhythmias. 2. Adult and pediatric populations requiring hemodynamic examinations, typically when the patient has a heart or vascular disease resulting in insufficient hemodynamic functionality.

SIEMENS Medical Solutions USA. Inc. intends to market the Sensis Vibe Hemo (VD15B) and Sensis Vibe Combo (VD15B), a hemodynamic and electrophysiological recording system. This 510(k) submission describes modifications to the previously cleared Primary Predicate Device the Sensis (K150493). Sensis Vibe Hemo (VD15B) and Sensis Vibe Combo (VD15B) is a multi-channel computer-based stationary system for the measurement, display, and printout of bio-physiological events. There are two configurations for this device: Sensis Vibe-Hemo and Sensis Vibe Combo. Hemodynamic and electrophysiologic signals such as intracardiac pressure, ECG signals, and intracardiac electrograms (ICEG) are measured and displayed by the system; several hemodynamic calculations are performed based on the measured values of the input signals. These data can be recorded in real-time and stored on removable media or in a digital DICOM archive. The Sensis Vibe Hemo (VD15B) and Sensis Vibe Combo (VD15B) system is comprised of the following basic hardware components: a small cabinet (video distribution box), front-end electronics, a keyboard with a mouse, and master and slave monitor(s) for real-time presentation of ECG tracings and pressure and ICEG waveforms. The small cabinet (video distribution box) contains power distribution electronics, video drivers, and a separation device for electrical isolation between the small cabinet and the signal input box. The front-end electronics contain modules for the acquisition of invasive blood pressure, ECG, SpO2, CO, and optionally ICEG and NBP, and are normally stalled at the operating table.

This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The images delivered by the system can be used by trained staff as an aid in diagnosis, treatment and radiation therapy planning as well as for diagnostic and therapeutic interventions. This CT system can be used for low dose lung cancer screening in high risk populations*. *As defined by professional medical societies. Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information.

The subject device SOMATOM CT Scanner Systems with SOMARIS/7 syngo CT VB30 are Computed Tomography X-ray Systems which feature one (single source) continuously rotating tube-detector system and function according to the fan beam principle. The SOMATOM CT Scanner Systems with Software SOMARIS/7 syngo CT VB30 produces CT images in DICOM format, which can be used by trained staff for post-processing applications commercially distributed by Siemens Healthcare and other vendors as an aid in diagnosis, treatment preparation and therapy planning support (including, but not limited to, Brachytherapy, Particle including Proton Therapy, External Beam Radiation Therapy, Surgery). The computer system delivered with the CT scanner is able to run optional post processing applications. The platform software for the SOMATOM CT Scanner Systems, SOMARIS/7 syngo CT VB30, is a commandbased program used for patient management, data management, X-ray scan control, image reconstruction, and image archive/evaluation.

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.

MAGNETOM Amira and MAGNETOM Sempra with syngo MR XA50M include new and modified features comparing to the predicate devices MAGNETOM Amira and MAGNETOM Sempra with syngo MR XA12M (K183221, cleared on February 14, 2019).

MAMMOVISTA B.smart is a dedicated softcopy review environment for both screening and diagnostic mammography as well as digital breast tomosynthesis. Its user interface and workflow have been optimized to support experienced mammography and tomosynthesis reviewers in both screening and diagnostic reading. Efficiency and reading quality are supported by various specialized features. MAMMOVISTA B.smart provides visualization and image enhancement tools to aid a qualified radiologist in the review of digital mammography and digital breast tomosynthesis datasets, as well as other modalities of breast images.

MAMMOVISTA B.smart is an optional software application for the Siemens Healthineers syngo.via platform (K191040). MAMMOVISTA B.smart is an image viewing and processing software environment dedicated to breast image display. It is designed to provide the performance required for the high data volume of digital tomosynthesis and the display of multi-modality breast images, such as those from MRI and ultrasound. Individual workflows can be adapted to either screening or diaqnostic purposes. MAMMOVISTA B.smart runs on a PC and can be used for Mammography image review together with monitors cleared for Mammography diagnostics. The software solution provides for the display of DICOM compatible information, such as breast density and CAD (Computer Aided Diagnostics) markers.

syngo.via RT Image Suite is a 3D and 4D image visualization, multi-modality manipulation and contouring tool that helps the preparation of treatments such as, but not limited to those performed with radiation (for example, Brachytherapy, Particle Therapy, External Beam Radiation Therapy). It provides tools to view existing contours, create, edit, modify, copy contours of regions of the body, such as but not limited to, skin outline, targets and organs-at-risk. It also provides functionalities to create simple geometric treatment plans. Contours, images and treatment plans can subsequently be exported to a Treatment Planning System. The software combines the following digital image processing and visualization tools: - . Multi-modality viewing and contouring of anatomical, and multi-parametric images such as but not limited to CT, PET, PET/CT, MRI, Linac CBCT images - 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 - Automated Contouring on CT images - . Creation of contours on images supported by the application without prior assignment of a planning CT - Manual and semi-automatic registration using rigid and deformable registration ● - . Supports the user in comparing, contouring, and adapting contours based on datasets acquired with different imaging modalities and at different time points - . Supports multi-modality image fusion - . Visualization and contouring of moving tumors and organs - Management of points of interest including but not limited to the isocenter ● - . Creation of simple geometric treatment plans - Generation of a synthetic CT based on multiple pre-define MR acquisitions ●

The subject device with the current software version SOMARIS/8 VB70 is an image analysis software for viewing, manipulation, 3D and 4D visualization, comparison of medical images from multiple imaging modalities and for the segmentation of tumors and organs-at-risk, prior to dosimetric planning in radiation therapy. syngo.via RT Image Suite combines routine and advanced digital image processing and visualization tools for manual and software assisted contouring of volumes of interest, identification of points of interest, sending isocenter points to an external laser system, registering images and exporting final results. syngo.via RT Image Suite supports the medical professional with tools to use during different steps in radiation therapy case preparation. For the current software version SOMARIS/8 VB70 the following already cleared features have been modified: - Patient Marking - Contouring - 4D Features ● - Basic Features of the subject device ●

The MAGNETOM system is indicated for use as a magnetic 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 inages and/ or spectra and the physical parameters derived from the images and/or spectra when interpreted by a trained physician vield 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.

MAGNETOM Lumina and MAGNETOM Vida Fit with software syngo MR XA50A include new software compared to the predicate devices, MAGNETOM Vida Fit with software syngo MR XA20A (K192924) and MAGNETOM Lumina with syngo MR XA31A (K203443). This software and some hardware components are transferred from the reference device MAGNETOM Vida with software syngo MR XA50A (K213693) as well as an imaging feature from MAGNETOM Vida with software syngo MR XA11A (K181433). A high-level summary of the transferred hardware and software is provided below: Hardware (Vida Fit only) Transferred Hardware: - The Nexaris Dockable Table is a new variant of the MR patient table which is used for intraoperative or interventional imaging. It enables the patient transfer between OR tables and the MR system without repositioning on the MR patient table and vice versa during interventional procedures and surgeries. Additionally, it can be used for diagnostic imaging. - The Nexaris Head Frame holds up to two Ultra Flex Large 18 coils. It can be used for head imaging in combination with the Nexaris Dockable Table when the patient is positioned on the transfer board but not pinned in a head clamp. - Transferred MaRS Computer Transferred Coil: - The Nexaris Spine 36 is used in combination with and without transfer board for body imaging on the Nexaris Dockable Table. Transferred modifications for hardware: - The Beat Sensor is a contact less method for generating cardiac triggers as an alternative to the already existing ECG or pulse triggers. It is based on a measurement of the modulation of a weak magnetic Pilot Tone, caused by conformation changes in conductive tissues. Software Transferred Features and Applications: Vida Fit only: - SVS EDIT is a special variant of the SVS SE pulse sequence type, which acquires two different spectra (one with editing pulses on resonance, one with editing pulses off resonance) within a single sequence. - BEAT FQ nav allows the user to make use of navigator echo based respiratory gating for flow imaging to acquire 4D flow data. Both navigator echo based respiratory gating as well as flow imaging are part of the predicate device already. New is merely the combination of both. - The HASTE interactive pulse sequence type extends the existing HASTE pulse sequence type by offering the possibility to interactively change imaging parameters. - GRE_WAVE is a special variant of the GRE pulse sequence type which allows larger acceleration factors, measuring one or two contrasts. GRE Wave results in higher signal-to-noise ratio for larger acceleration factors which can be leveraged to allow fast high-resolution 3D susceptibility-weighted imaging. - The myExam Prostate Assist provides an assisted and quided workflow for prostate imaging. This automated workflow leads to higher reproducibility of slice angulation and coverage; this may support exams not having to be repeated. - Iniector coupling is a software application that allows the connection of certain contrast agent injectors to the MR system for simplified, synchronized contrast injection and examination start. Lumina onlv: - Compressed Sensing GRASP-VIBE is intended to be used in dynamic and/or non-contrast liver examinations to support patients who cannot reliably hold their breath for a conventional breath-hold measurement. Lumina and Vida Fit: - Deep Resolve Swift Brain is a protocol for fast routine brain imaging primarily based on echo planar imaging (EPI) pulse sequences. Its main enablers are multi-shot (ms) EPI pulse sequence types and a deep learning-based image reconstruction. - Deep Resolve Boost is a novel deep learning-based image reconstruction alqorithm for 2D TSE data, which reconstructs images from k-space raw-data. - BLADE diffusion is a multi-shot imaging method based on TSE or TGSE (when EPI factor > 1) readout and a BLADE trajectory with diffusion preparation to enable diffusion weighted imaging with reduced sensitivity to B0 inhomogeneity and reduced T2 decay caused image blurring. - HASTE diffusion (HASTE DIFF) is a single-shot imaging method based on TSE readout with diffusion preparation to enable diffusion weighted imaging with reduced sensitivity to B0 inhomogeneity. Transferred Modifications for Features and Applications: Vida Fit only: - The AbsoluteShim mode is a shimming procedure based on a 3-echo gradient echo protocol. - The 3D ASL sequence (tgse_asl) now provides relCBF maps, by implementing an additional M0 scan and performing the corresponding reconstruction method. It also provides BAT maps in multiple inversion time(multi-TI) imaging. Lumina and Vida Fit: - Fast GRE RefScan: A speed-optimized reference scan for GRAPPA and SMS kernel calibration for echo planar imaging pulse sequence types. - Static Field Correction is a reconstruction option reducing susceptibilityinduced distortions and intensity variations. - Deep Resolve Sharp is an interpolation algorithm which increases the perceived sharpness of the interpolated images. Functionality is available for different pulse sequence types. (Newly transferred to Vida Fit) - Deep Resolve Gain is a reconstruction option which improves the SNR of the scanned imaqes. Functionality is available for different pulse sequence types. (Newly transferred to Vida Fit) - The myExam Angio Advanced Assist provides an assisted and quided workflow for peripheral angiography examination using care bolus. The main advantage of this new workflow is a simplified and improved planning procedure of multi-station peripherical angiography measurements. Other transferred Modifications and / or Minor Changes Vida Fit only: - Elastography-AddIn synchronizes settings between the Elastography sequence and the active driver. - HASTE MoCo is an image-based motion correction in the average-dimension for the HASTE pulse sequence type. - Coil independent pulse sequences remove the coil information from the pulse sequences and generate this information during run-time from automatic coil detection and localization. - The Needle Intervention AddIn provides a user interface for workflow improvement of MR-quided needle interventions under real-time imaging conditions. It supports planning a needle trajectory, laser-based localization of the entry point as well as automatic slice positioning. - The PhaseRev Dot Addin/Component supports the measurement workflow of the user by automatically flipping the direction of the phase encoding gradient. - The adjustment mode "offcenter" triggers a transmitter adjustment method that is specialized for offcenter imaging. The transmitter adjustment determines the RF voltage that is required to excite a certain B1 field. Lumina and Vida Fit: - TSE MoCo is an image-based motion correction in the average-dimension for the TSE pulse sequence type. - MR Breast Biopsy is improved with an automatic fiducial detection.

syngo.CT Dual Energy is designed to operate with CT images based on two different X-ray spectra. The various materials of an anatomical region of interest have different attenuation coefficients, which depend on the used energy. These differences provide information on the chemical composition of the scanned body materials. syngo.CT Dual Energy combines images acquired with low and high energy spectra to visualize this information. Depending on the region of interest, contrast agents may be used. The general functionality of the syngo.CT Dual Energy application is as follows: - · Monoenergetic 1) - · Brain Hemorrhage - · Gout Evaluation - · Lung Vessels - · Heart PBV - · Bone Removal - · Lung Perfusion - · Liver VNC - · Monoenergetic Plus 1) - · Virtual Unenhanced 1) - Bone Marrow - · Hard Plaques - Rho/Z - · Kidney Stones 2) - · SPR (Stopping Power Ratio) - · SPP (Spectral Post-Processing Format) 1) - · Optimum Contrast 1) The availability of each feature depends on the Dual Energy scan mode. 1) This functionality supports data from Photon-Counting CT scanners. 2) Kidney Stones is designed to support the visualization of the chemical composition of kidney stones and especially the differentiation between uric acid stones. For full identification of the kidney stone, additional clinical information should be considered such as patient history and urine testing. Only a well-trained radiologist can make the final diagnosis upon consideration of all available information. The accuracy of identification is decreased in obese patients.

Dual energy offers functions for qualitative and quantitative post-processing evaluations. syngo.CT Dual Energy is a post-processing application consisting of several post-processing application classes that can be used to improve the visualization of the chemical composition of various energy dependent materials in the human body when compared to single energy CT. Depending on the organ of interest, the user can select and modify different application classes or parameters and algorithms. Different body regions require specific tools that allow the correct evaluation of data sets. syngo.CT Dual Energy provides a range of application classes that meet the requirements of each evaluation type. The different application classes for the subject device can be combined into one workflow.

syngo.CT Applications is a set of software applications for advanced visualization, measurement, and evaluation for specific body regions. This software package is designed to support the radiologists and physicians from emergency medicine, specialty care, urgent care, and general practice e.g. in the: - · Evaluation of perfusion of organs and tumors and myocardial tissue perfusion - · Evaluation of bone structures and detection of bone lesions - · Evaluation of CT images of the heart - · Evaluation of the coronary lesions - · Evaluation of the mandible and maxilla - · Evaluation of dynamic vessels and extended phase handling - · Evaluation of the liver and its intrahepatic vessel structures to identify the vascular territories of sub-vessel systems in the liver - · Evaluation of neurovascular structures - Evaluation of the lung parenchyma - · Evaluation of non-enhanced Head CT images - · Evaluation of vascular lesions

The syngo.CT Applications are syngo based post-processing software applications to be used for viewing and evaluating CT images provided by a CT diagnostic device and enabling structured evaluation of CT images. The syngo.CT Applications is a combination of thirteen (13) former separately cleared medical devices which are now handled as features / functionalities within syngo.CT Applications. These functionalities are combined unchanged compared to their former cleared descriptions; however, some minor enhancements and improvements are made for the application syngo.CT Pulmo 3D only.

syngo.via RT Image Suite is a 3D and 4D image visualization, multi-modality manipulation and contouring tool that helps the preparation of treatments such as, but not limited to those performed with radiation (for example, Brachytherapy, Particle Therapy, External Beam Radiation Therapy). It provides tools to view existing contours, create, edit, modify, copy contours of regions of the body, such as but not limited to, skin outline, targets and organs-at-risk. It also provides functionalities to create simple geometric treatment plans. Contours, images and treatment plans can subsequently be exported to a Treatment Planning System. The software combines the following digital image processing and visualization tools: - . Multi-modality viewing and contouring of anatomical, and multi-parametric images such as but not limited to CT, PET, PET/CT, MRI, Linac CBCT images - 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 - Automated Contouring on CT images - . Creation of contours on images supported by the application without prior assignment of a planning CT - Manual and semi-automatic registration using rigid and deformable registration - Supports the user in comparing, contouring, and adapting contours based on datasets acquired with different imaging modalities and at different time points - . Supports multi-modality image fusion - . Visualization and contouring of moving tumors and organs - Management of points of interest including but not limited to the isocenter ● - Creation of simple geometric treatment plans ● - Generation of a synthetic CT based on multiple pre-define MR acquisitions ●

The subject device with the current software version SOMARIS/8 VB60 is an image analysis software for viewing, manipulation, 3D and 4D visualization, comparison of medical images from multiple imaging modalities and for the segmentation of tumors and organs-at-risk, prior to dosimetric planning in radiation therapy. syngo.via RT Image Suite combines routine and advanced digital image processing and visualization tools for manual and software assisted contouring of volumes of interest, identification of points of interest, sending isocenter points to an external laser system, registering images and exporting final results. syngo.via RT Image Suite supports the medical professional with tools to use during different steps in radiation therapy case preparation. For the current software version SOMARIS/8 VB60 the following already cleared features have been modified: - . Reference Point Management - Patient Marking ● - Contouring / Routine Contouring - Structure Set Management ● - Synthetic CT - Basic Feature of syngo,via RT Image Suite

AI-Rad Companion Prostate MR is a post-processing image analysis software that assists clinicians in viewing, manipulating, analyzing and evaluating MR prostate images for US guided MR-US fusion biopsy support.

AI-Rad Companion Prostate MR aims to assist the radiologist in the preparation of MR prostate images for targeted biopsies of the prostate gland using MR-Ultrasound fusion biopsy. It allows the radiologist to communicate the location and spatial extent of lesions and the prostate volume in prostate MR images to a urologist in order to help perform biopsies. AI-Rad Companion Prostate MR is a cloud-based image processing software that provides quantitative and qualitative information based on prostate MR DICOM images. More specifically, it provides information on the prostate volume which can be used to support the planning of prostate biopsies in the case of ultrasound guided MR-US fusion biopsies of the prostate gland. It is enabled via artificial intelligence algorithms and a cloud infrastructure. The primary features of AI-Rad Companion Prostate MR include: - Automatic prostate segmentation and volume estimation, with the possibility of manual adjustments - Manual determination of location and size of lesions in a suitable user interface - Calculation of the PSA density, based on the input of the PSA value of the patient by the clinical user - Export in a suitable format for reading and archiving in PACS, as well as in a second format that can be imported by ultrasound systems (e.g. RTStruct), allowing the urologist to perform targeted MR-US fusion biopsy