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The intended use of the device YSIO X.pree is to visualize anatomical structures of human beings by converting an X-ray pattern into a visible image. The device is a digital X-ray system to generate X-ray images from the whole body including the skull, chest, abdomen, and extremities. The acquired images support medical professionals to make diagnostic and/or therapeutic decisions. YSIO X.pree is not for mammography examinations.

The YSIO X.pree is a radiography X-ray system. It is designed as a modular system with components such as a ceiling suspension with an X-ray tube, Bucky wall stand, Bucky table, X-ray generator, portable wireless, and fixed integrated detectors that may be combined into different configurations to meet specific customer needs. The following modifications have been made to the cleared predicate device: - Updated generator - Updated collimator - Updated patient table - Updated Bucky Wall Stand - New X.wi-D 24 portable wireless detector - New virtual AEC selection - New status indicator lights

The Siemens PET/CT systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information. The CT component produces 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. The PET subsystem images and measures the distribution of PET radiopharmaceuticals in humans for the purpose of determining various metabolic (molecular) and physiologic functions within the human body and utilizes the CT for fast attenuation correction maps for PET studies and precise anatomical reference for the fused PET and CT images. The system maintains independent functionality of the CT and PET devices, allowing for single modality CT and/or PET diagnostic imaging. These systems are intended to be utilized by appropriately trained health care professionals to aid in detecting, localizing, diagnosing, staging and restaging of lesions, tumors, disease and organ function for the evaluation of diseases and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The images produced by the system can also be used by the physician to aid in radiotherapy treatment planning and interventional radiology procedures. This 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.

Biograph Trinion PET/CT systems are combined multi-slice X-Ray Computed Tomography and Positron Emission Tomography scanners. This system is designed for whole body oncology, neurology and cardiology examinations. Biograph Trinion PET/CT systems provide registration and fusion of high-resolution metabolic and anatomic information from the two major components of each system (PET and CT). Additional components of the system include a patient handling system and acquisition and processing workstations with associated software. Biograph Trinion VK20 software is a command-based program used for patient management, data management, scan control, image reconstruction and image archival and evaluation. All images conform to DICOM imaging format requirements. Biograph PET/CT systems, which are the subject of this application, are substantially equivalent to the commercially available Biograph Trinion VK10 family of PET/CT systems (K233677). Differences compared to the commercially available Biograph Trinion systems include: - The commercially available SOMATOM go.All and go.Top systems with VB10 (K233650) software have been incorporated into the Biograph Trinion VK20 systems, including commercially available CT features. - Additional PET axial field of view (FoV) systems allowing for more scalability. - Additional patient communication and comfort features. - PET respiratory gating with an external gating device has been implemented. The Biograph Trinion models may also use the names Biograph Mission, Biograph Wonder, Biograph Ambition and Biograph Devotion for marketing purposes.

The Cios Spin is a mobile X-ray system designed to provide X-ray imaging of the anatomical structures of patients during clinical applications. Clinical applications may include but are not limited to interventional fluoroscopic, gastro-intestinal, endoscopic, urologic, pain management, orthopedic, neurologic, vascular, cardiac, critical care, and emergency room procedures. The patient population may include pediatric patients.

The Cios Spin (VA31A) mobile fluoroscopic C-arm X-ray System is designed for the surgical environment. The Cios Spin provides comprehensive image acquisition modes to support orthopedic and vascular procedures. The system consists of two major components: a. The C-arm with X-ray source on one side and the flat panel detector on the opposite side. The c-arm can be angulated in both planes and be lifted vertically, shifted to the side and move forward/backward by an operator. b. The second unit is the image display station with a moveable trolley for the image processing and storage system, image display and documentation. Both units are connected to each other with a cable. The following modifications were made to the Predicate Device the Cios Spin Mobile X-ray System cleared under Premarket Notification K210054 on February 5, 2021. Siemens Medical Solutions USA, Inc. submits this Traditional 510(k) to request clearance for the Subject Device Cios Spin (VA31A). The following modification is incorporated in the Predicate Device to create the Subject Device, for which Siemens is seeking 510(k) clearance: 1. Software updated from VA30 to VA31A to support the below software features A. Updated Retina 3D for optional enlarged 3D Volume of 25cm x 25cm x 16cm B. Introduction of NaviLink 3D Lite C. Universal Navigation Interface (UNI) D. Updated InstantLink with Extended NXS Interface 2. Updated Collimator 3. Updated FLC Imaging system PC with new PC hardware Updated AppHost PC with High Performance Graphic Card 4. New Eaton UPS 5P 850i G2 as successor of UPS 5P 850i due to obsolescense

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 a 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.

Siemens intends to update the software version syngo CT VB20 (update) for the following NAEOTOM Alpha class CT systems: Dual Source NAEOTOM CT scanner systems: - NAEOTOM Alpha (trade name ex-factory CT systems: NAEOTOM Alpha.Peak; trade name installed base CT systems with SW upgrade only: NAEOTOM Alpha) For simplicity, the product name of NAEOTOM Alpha will be used throughout this submission instead of the trade name NAEOTOM Alpha.Peak. - NAEOTOM Alpha.Pro Single Source NAEOTOM CT scanner system: - NAEOTOM Alpha.Prime The subject devices NAEOTOM Alpha (trade name ex-factory CT systems: NAEOTOM Alpha.Peak) and NAEOTOM Alpha.Pro with software version SOMARIS/10 syngo CT VB20 (update) are Computed Tomography X-ray systems which feature two continuously rotating tube-detector systems, denominated as A- and B-systems respectively (dual source NAEOTOM CT scanner system). The subject device NAEOTOM Alpha.Prime with software version SOMARIS/10 syngo CT VB20 (update) is a Computed Tomography X-ray system which features one continuously rotating tube-detector systems, denominated as A-system (single source NAEOTOM CT scanner system). The detectors' function is based on photon-counting technology. In this submission, the above-mentioned CT scanner systems are jointly referred to as subject devices by "NAEOTOM Alpha class CT scanner systems". The NAEOTOM Alpha class CT scanner systems with SOMARIS/10 syngo CT VB20 (update) produce CT images in DICOM format, which can be used by trained staff for post-processing applications commercially distributed by Siemens and other vendors. The CT images can be used by a trained staff as an aid in diagnosis, treatment and radiation therapy planning as well as for diagnostic and therapeutic interventions. The radiation therapy planning support includes, but is not limited to, Brachytherapy, Particle Therapy including Proton Therapy, External Beam Radiation Therapy, Surgery. The computer system delivered with the CT scanner is able to run optional post-processing applications. Only trained and qualified users, certified in accordance with country-specific regulations, are authorized to operate the system. For example, physicians, radiologists, or technologists. The user must have the necessary U.S. qualifications in order to diagnose or treat the patient with the use of the images delivered by the system. The platform software for the NAEOTOM Alpha class CT scanner systems is syngo CT VB20 (update) (SOMARIS/10 syngo CT VB20 (update)). It is a command-based program used for patient management, data management, X-ray scan control, image reconstruction, and image archive/evaluation. The software platform provides plugin software interfaces that allow for the use of specific commercially available post-processing software algorithms in an unmodified form from the cleared stand-alone post-processing version. Software version syngo CT VB20 (update) (SOMARIS/10 syngo CT VB20 (update)) shall support additional software features compared to the software version of the predicate devices NAEOTOM Alpha class CT systems with syngo CT VB20 (SOMARIS/10 syngo CT VB20) cleared in K243523. Software version SOMARIS/10 syngo CT VB20 (update) will be offered ex-factory and as optional upgrade for the existing NAEOTOM Alpha class systems. The bundle approach is feasible for this submission since the subject devices have similar technological characteristics, software operating platform, and supported software characteristics. All subject devices will support previously cleared software and hardware features in addition to the applicable modifications as described within this submission. The intended use remains unchanged compared to the predicate devices.

LUMINOS Q.namix T and LUMINOS Q.namix R are devices intended to visualize anatomical structures by converting an X-ray pattern into a visible image. It is a multifunctional, general R/F system, suitable for routine radiography and fluoroscopy examinations, including gastrointestinal- and urogenital examinations and specialist areas like arthrography, angiography and pediatrics. LUMINOS Q.namix T and LUMINOS Q.namix R are not intended to be used for mammography examinations.

The LUMINOS Q.namix T is an under-table fluoroscopy system and the LUMINOS Q.namix R is an over-table fluoroscopy system. Both systems are multifunctional, general R/F systems, suitable for routine radiography and fluoroscopy examinations, including gastrointestinal- and urogenital examinations and specialist areas like arthrography, angiography and pediatrics. They are designed as modular systems with components such as main fluoro table including fixed fluoroscopy detector and X-ray tube, a ceiling suspension with X-ray tube, Bucky wall stand, X-ray generator, monitors, a bucky tray in the table as well as portable wireless and fixed integrated detectors that may be combined into different configurations to meet specific customer needs.

The Cios Alpha is a mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications. Clinical applications may include, but are not limited to: interventional fluoroscopic, gastro-intestinal, endoscopic, urologic, pain management, orthopedic, neurologic, vascular, cardiac, critical care, and emergency room procedures. The patient population may include pediatric patients. The Cios Flow is a mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications. Clinical applications may include, but are not limited to: interventional fluoroscopic, gastro-intestinal, endoscopic, urologic, pain management, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures. The patient population may include pediatric patients.

The Cios Alpha and Cios Flow (VA31A) mobile fluoroscopic C-arm X-ray System is designed for the surgical environment. The Cios Alpha and Cios Flow provide comprehensive image acquisition modes to support orthopedic and vascular procedures. The system consists of two major components: a) The C-arm with X-ray source on one side and the flat panel detector on the opposite side. The C-arm can be angulated in both planes and lifted vertically, shifted to the side, and moved forward/backward by an operator. b) The second unit is the image display station with a movable trolley for the image processing and storage system, image display, and documentation. Both units are connected with a cable. The main unit is connected to the main power outlet, and the trolley is connected to a data network. The following modifications were made to the predicate device Cios Alpha and Cios Flow. Siemens Medical Solutions USA, Inc. submits this Bundled Traditional 510k to request clearance for Subject Devices Cios Alpha and Cios Flow (VA31A) for the following device modifications made to the Predicates Device Cios Alpha and Cios Flow (VA30). This 510k submission, Subject Devices "Cios Alpha" and "Cios Flow" with software version VA31A, will support the following categories of modifications made to the Subject Devices in comparison to the Predicate Devices: 1. Software updated from VA30 to VA31A to support the following software features: A. Updated InstantLink with Extended NXS Interface 2. Updated Collimator 3. New optional flat detector Trixell Pixium 3131SOD with IGZO (Indium Gallium Zinc Oxide) technology 4. Updated FLC imaging system with new PC hardware Updated the High Performance Graphic Card on the Apphost PC 5. Updated Eaton UPS 5P 850i G2 as successor of UPS 5P 850i due to obsolescense 6. The Cios Alpha is also known as "Cios Alpha.neo" The Cios Flow is also known as Cios Flow.neo

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 a 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.

Siemens intends to market a new software version, SOMARIS/10 syngo CT VB20 for the following SOMATOM Computed Tomography (CT) Scanner Systems: a) Single Source CT Scanner systems (SOMATOM go. Platform): - SOMATOM go.Now - SOMATOM go.Up - SOMATOM go.All - SOMATOM go.Top - SOMATOM go.Sim - SOMATOM go.Open Pro In this submission, the above listed CT scanner systems are jointly referred to as subject devices by "SOMATOM go. Platform" CT scanner systems. b) Dual Source CT Scanner system: - SOMATOM Pro.Pulse The above listed subject devices with SOMARIS/10 syngo CT VB20 are Computed Tomography X-ray Systems which feature one (Single Source) or two (Dual Source) continuously rotating tube-detector system and function according to the fan beam principle. The SOMATOM go. Platform and the SOMATOM Pro.Pulse with software SOMARIS/10 syngo CT VB20 produce CT images in DICOM format, which can be used by trained staff for software applications, e.g. 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.

syngo.via molecular imaging (MI) workflows comprise medical diagnostic applications for viewing, manipulation, quantification, analysis and comparison of medical images from single or multiple imaging modalities with one or more time-points. These workflows support functional data, such as positron emission tomography (PET) or nuclear medicine (NM), as well as anatomical datasets, such as computed tomography (CT) or magnetic resonance (MR). syngo.via MI workflows can perform harmonization of SUV (PET) across different PET systems or different PET reconstruction methods. syngo.via MI workflows are intended to be utilized by appropriately trained health care professionals to aid in the management of diseases, including those associated with oncology, cardiology, neurology, and organ function. The images and results produced by the syngo.via MI workflows can also be used by the physician to aid in radiotherapy treatment planning.

syngo.via MI Workflows (including Scenium and syngo MBF applications) is a multi-modality post-processing software only medical device intended to aid in the management of diseases, including those associated with oncology, cardiology, neurology, and organ function. The syngo.via MI Workflows applications are part of a larger syngo.via client/server system which is intended to be installed on common IT hardware. The hardware itself is not seen as part of the syngo.via MI Workflows medical device. The syngo.via MI Workflows software addresses the needs of the following typical users of the product: - **Reading Physician / Radiologist** – Reading physicians are doctors who are trained in interpreting patient scans from PET, SPECT and other modality scanners. They are highly detail oriented and analyze the acquired images for abnormalities, enabling ordering physicians to accurately diagnose and treat scanned patients. Reading physicians serve as a liaison between the ordering physician and the technologists, working closely with both. - **Technologist** – Nuclear medicine technologists operate nuclear medicine scanners such as PET and SPECT to produce images of specific areas and states of a patient's anatomy by administering radiopharmaceuticals to patients orally or via injection. In addition to administering the scan, the technologist must properly select the scan protocol, keep the patient calm and relaxed, monitor the patient's physical health during the protocol and evaluate the quality of the images. Technologists work very closely with physicians, providing them with quality-checked scan images. The software has been designed to integrate the clinical workflow for the above users into a server-based system that is consistent in design and look with the base syngo.via platform and other syngo.via software applications. This ensures a similar look and feel for radiologists that may review multiple types of studies from imaging modalities other than Molecular Imaging, such as MR. The syngo.via MI workflows software supports integration through DICOM transfers of positron emission tomography (PET) or nuclear medicine (NM) data, as well as anatomical datasets, such as computed tomography (CT) or magnetic resonance (MR). Although data is automatically imported into the server based on predefined configurations through the hospital IT system, data can also be manually imported from external media, including CD, external mass storage devices, etc. The Siemens syngo.via platform and the applications that reside on it, including syngo.via MI Workflows, are distributed via electronic medium. The Instructions for Use is also delivered via electronic medium. syngo.via MI Workflows includes 2 workflows (syngo.MM Oncology and syngo.MI General) as well as the Scenium neurology software application and the syngo MBF cardiology software application which are launched from the OpenApps framework within the MI General workflow.

The Siemens Biograph systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information. The CT component produces 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. The PET subsystem images and measures the distribution of PET radiopharmaceuticals in humans for the purpose of determining various metabolic (molecular) and physiologic functions within the human body and utilizes the CT for fast attenuation correction maps for PET studies and precise anatomical reference for the fused PET and CT images. The system maintains independent functionality of the CT and PET devices, allowing for single modality CT and/or PET diagnostic imaging. These systems are intended to be utilized by appropriately trained health care professionals to aid in detecting, localizing, diagnosing, staging, and restaging of lesions, tumors, disease, and organ function for the evaluation of diseases and disorders such as, but not limited to, cardiovascular disease, neurological disorders, and cancer. The images produced by the system can also be used by the physician to aid in radiotherapy treatment planning and interventional radiology procedures. 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 Biograph Vision and Biograph mCT PET/CT systems are combined multi-slice X-Ray Computed Tomography and Positron Emission Tomography scanners. These systems are designed for whole-body oncology, neurology and cardiology examinations. The Biograph Vision and Biograph mCT systems provide registration and fusion of high-resolution metabolic and anatomic information from the two major components of each system (PET and CT). Additional components of the system include a patient handling system and acquisition and processing workstations with associated software. Biograph Vision and Biograph mCT software is a command-based program used for patient management, data management, scan control, image reconstruction and image archival and evaluation. All images conform to DICOM imaging format requirements. The software for the Biograph Vision and Biograph mCT systems, which are the subject of this application, is substantially equivalent to the commercially available Biograph Vision and Biograph mCT software. - **Somaris Software** (cleared in K230421) - Upgrade to the latest revision of Somaris Software (Somaris/7 syngo CT VB30) with modified software features: - FAST Bolus - FAST 4D - FAST Applications (FAST Spine, FAST Planning) - Automatic Patient Instructions - Additional default exam protocols - Additional kV setting for Tin Filtration - **PETsyngo software** - SMART Image Framer (available for Vision 600 and X models only – cleared in K223547) - Updated computer hardware due to obsolescence issues (cleared in K230421). These changes do not affect system performance characteristics and have no impact on safety or effectiveness. The Biograph Vision may also use the names Biograph Vision Quantum and Peak for marketing purposes.

The Atellica IM Thyroglobulin (Tg) assay is for in vitro diagnostic use in the quantitative measurement of thyroglobulin in human serum and plasma (EDTA and lithium heparin) using the Atellica IM Analyzer. Thyroglobulin measurements are used as an aid in monitoring differentiated thyroid cancer patients who have undergone thyroidectomy with or without radioiodine ablation.

The Atellica IM Thyroglobulin (Tg) assay includes: - **Tg ReadyPack primary reagent pack:** - **Lite Reagent:** mouse monoclonal anti-human Tg antibody labeled with acridinium ester (~1.13 μg/mL); bovine serum albumin (BSA); mouse IgG; buffer; stabilizers; preservatives (7.5 mL/reagent pack). - **Solid Phase:** streptavidin-coated paramagnetic microparticles preformed with biotinylated mouse monoclonal antihuman Tg antibody (~267 μg/mL); BSA; mouse IgG; buffer; stabilizers; preservatives (15.0 mL/reagent pack). - **Ancillary Well Reagent:** BSA; bovine gamma globulin; buffer; preservatives (6.0 mL/reagent pack). - **Tg CAL:** After reconstitution, human thyroglobulin; BSA; buffer; stabilizers; preservatives (2.0 mL/vial). The following devices are sold separately: - **Atellica IM Tg MCM:** - **MCM 1:** After reconstitution, bovine serum albumin (BSA); buffer; stabilizers; preservatives (1.0 mL/vial). - **MCM 2–5:** After reconstitution, various levels of human thyroglobulin; BSA; buffer; stabilizers; preservatives (1.0 mL/vial).