Search Results

syngo.CT LVO Detection is a radiological post-processing application for the analysis of CT angiography (CTA) head images. syngo.CT LVO Detection supports computer-aided triage, and it addresses vascular abortions in the CTA of the brain, commonly referred to as large vessel occlusion (LVO), in the ICA, M1, and M2 segment. It is intended for all patient populations of age ≥ 22 years, without any of the following contraindications: old infarcts or other diseases impacting the brain vasculature (for example, brain tumors), metal artifacts (for example, coils), surgical signs in the images. The output for triage is intended for informational purposes only. It is not intended for diagnostic use and does not alter the original medical image.

The subject device syngo.CT LVO Detection is an image processing software that utilizes artificial intelligence learning algorithms to support qualified clinicians (Radiologists, Neuroradiologists, Neurologists) in prioritization of CT-angiography images by algorithmically identifying findings suspicious of a large vessel occlusion and providing notification to the user. syngo.CT LVO Detection provides a reproducible detection of large vessel occlusions (LVO) on contrast-enhanced CT examinations of the head for detection of ICA, M1, and M2 vessel occlusions in patients suspected of having stroke related circulation occlusion. syngo.CT LVO Detection analyses CT-angiography (CTA) images of the head. The subject device provides a pipeline for the analysis and identification of potential LVO The output which can be send to an external notification device does not highlight or direct attention of the reading physician to any portion of the image.

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 Single source CT system NAEOTOM Alpha.Prime and a new Dual Source CT system NAEOTOM Alpha.Pro based on the SOMARIS/10 software platform. Siemens also intends to market updated software version, SOMARIS/10 syngo CT VB20, for the new NAEOTOM CT scanner systems and for the NAEOTOM Alpha cleared in K233657 (clearance date March 28th, 2024). The updated software version SOMARIS/10 syngo CT VB20 incorporates mainly features for radiotherapy planning support. With the new software version SOMARIS/10 syngo CT VB20, the trade name of NAEOTOM Alpha cleared in K233657 has been changed to NAEOTOM Alpha.Peak for ex-factory systems. Systems already installed will receive the software update without change of the trade name. The system label keeps the product name NAEOTOM Alpha. System label information and UDI are not changed and remain the same as the original submitted. For simplicity, the product name of NAEOTOM Alpha will be used throughout this submission instead of the trade name NAEOTOM Alpha.Peak. 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 are Computed Tomography X-ray systems which feature two continuously rotating tube-detector systems, denominated as Aand B-systems respectively (dual source NAEOTOM CT scanner system). The subject device NAEOTOM Alpha.Prime with software version SOMARIS/10 syngo CT VB20 is a Computed Tomography X-ray system which features one continuously rotating tube-detector systems, denominated as A-system (single source NAEOTOM Alpha 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 CT scanner systems". The NAEOTOM CT scanner systems with SOMARIS/10 syngo CT VB20 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 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. 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 CT scanner systems is syngo CT VB20 (SOMARIS/10 syngo CT VB20). 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 (SOMARIS/10 syngo CT VB20) is a modified software version of the primary predicate device NAEOTOM Alpha, syngo CT VB10 (SOMARIS/10 syngo CT VB10) cleared in K233657. Software version SOMARIS/10 syngo CT VB20 will be offered ex-factory and as optional upgrade for the existing NAEOTOM Alpha 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.

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 1) - · Gout Evaluation 1) - · Lung Vessels 1) - · Heart PBV - · Bone Removal - · Lung Perfusion 1) - · Lung Mono 1 ) - · Liver VNC 1) - · Monoenergetic Plus 1) - · Virtual Unenhanced 1) - Bone Marrow - · Hard Plaques - Rho/Z - · Kidney Stones 1) 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 Siemens Healthineers Photon-Counting CT scanners acquired in QuantumPlus modes. 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.

ACUSON Sequoia and Sequoia Select The ACUSON Sequoia and Sequoia Select ultrasound imaging systems are intended to provide images of, or signals from, inside the body by an appropriately trained healthcare professional in a clinical setting for the following applications: Fetal, Abdominal, Pediatric, Neonatal Cephalic, Small Parts, OB/GYN (useful for visualization of the ovaries, follicles, uterus and other pelvic structures), Cardiac, Transesophageal, Pelvic, Vascular, Adult Cephalic, Musculoskeletal and Peripheral Vascular applications. The system supports the Ultrasonically-Derived Fat Fraction (UDFF) measurement tool to report an index that can be useful as an aid to a physician managing adult and pediatric patients with hepatic steatosis. The system also provides the ability to measure anatomical structures for fetal, abdominal, pediatric, small organ, cardiac, transvaginal, peripheral vessel, musculoskeletal and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes. ACUSON Origin and Origin ICE The ACUSON Origin and Origin ICE ultrasound imaging systems are intended to provide images of. or signals from, inside the body by an appropriately trained healthcare professional in a clinical setting for the following applications: Fetal, Abdominal, Pediatric. OB/GYN (useful for visualization of the ovaries, follicles, uterus and other pelvic structures), Cardiac, Transesophageal, Intracardiac, Vascular, Adult Cephalic, and Peripheral Vascular applications. The catheter is intended for intracardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart of adult and pediatric patients. The catheter is intended for imaging guidance only, not treatment delivery, during cardiac interventional percutaneous procedures. The system also provides the ability to measure anatomical structures for fetal, abdominal, pediatric, cardiac, peripheral vessel, and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.

The ACUSON Sequoia, Sequoia Select, Origin and Origin ICE Diagnostic Ultrasound Systems are multi-purpose, mobile, software-controlled, diagnostic ultrasound systems with an on-screen display of thermal and mechanical indices related to potential bioeffect mechanisms. The ultrasound system function is to transmit and receive ultrasound echo data and display it in B-Mode, M-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Color M Mode, Doppler Tissue Mode, Amplitude Doppler Mode, a combination of modes, Panoramic Imaging, Contrast agent Imaging, Virtual Touch Strain Imaging (except Origin), Virtual Touch - pSWE Imaging, Virtual Touch - SWE Imaging, Custom Tissue Imaging, 3D/4D Volume lmaging or Harmonic Imaging on a Display and provide cardiac anatomical and quantitative function software applications.

The ACUSON Redwood ultrasound imaging system is intended to provide images of, or signals from, inside the body by an appropriately trained healthcare professional in a clinical setting for the following applications: Fetal, Abdominal, Pediatric, Small Parts, OB/GYN (useful for visualization of the ovaries, follicles, uterus, and other pelvic structures), Adult, Pediatric and Neonatal Cardiac, Pelvic, Neonatal Cephalic, Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, Transcranial, and Peripheral Vascular. The system supports the Ultrasound-Derived Fat Fraction (UDFF) measurement tool to report an index that can be useful as an aid to a physician managing adult patients with hepatic steatosis. The system also provides the ability to measure anatomical structures: fetal, abdominal, pediatric, small organ, neonatal cephalic, adult cephalic, cardiac (adult, pediatric and neonatal), transesophageal, transrectal, transvaginal, peripheral vessel, musculoskeletal (conventional), musculoskeletal (superficial), and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.

The ACUSON Redwood Diagnostic Ultrasound System is multi-purpose, mobile, softwarecontrolled, diagnostic ultrasound system with an on-screen display for thermal and mechanical indices related to potential bio-effect mechanisms. Its function is to acquire harmonic ultrasound echo data and display it in B-Mode, M-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Color M mode, Doppler Tissue Image mode, Amplitude Doppler Mode, Combination modes, Harmonic Imaging and 3D Imaging modes, and 4D imaging modes on a flat panel display for diagnostic ultrasound imaging.

The Symbia Pro.specta systems are intended for use 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 or additional uses. SPECT: The SPECT component is intended to detect or image the distribution of radionuclides in the body or organ (physiology), using the following techniques: planar imaging, whole body imaging, and tomographic imaging for isotopes with energies up to 588 keV. CT: The CT component is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data (anatomy) from either the same axial plane taken at different angles or spiral planes taken at different angles. SPECT+CT: The SPECT and CT components used together acquire SPECT/CT images. The SPECT images can be corrected for attenuation with the CT images, and can be combined (image registration) to merge the patient's physiological (SPECT) and anatomical (CT) images. Software: The SPECTsyngo software is an acquisition, display and analysis package intended to aid the clinician in the assessment and quantification of pathologies in images produced from SPECT, PET. CT. and other imaging modalities. 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. There are no known contraindications.

The Siemens Symbia Pro.specta VA30A Family consists of Single-Photon Emission Computed Tomography (SPECT) scanner and integrated hybrid x-ray Computed Tomography (CT) and SPECT scanner. The SPECT subsystem images and measures the distribution of radiopharmaceuticals in humans for the purpose of determining various metabolic (molecular) and physiologic functions within the human body and integrates CT's anatomical detail for precise reference of the location of the metabolic activity. 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 system can be used as an integrated SPECT and CT modality while also enabling independent functionality of SPECT and CT as stand-alone diagnostic imaging devices. Siemens Symbia Pro.specta VA30A Family maintains the same intended use and indications for use as the commercially available Symbia Pro.specta VA20A family (K231102). Symbia Pro.specta VA30A Family are hybrid modality imaging systems comprised of two separate but integrated components: a gamma camera (SPECT) and a CT. The gamma camera is based on hardware and software features that generate nuclear medicine images based on the uptake of radioisotope tracers in a patient's body. The CT system (spiral CT) is designed 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. The combination of SPECT and CT in a single device has several benefits. The SPECT subsystem images biochemical function while the CT subsystem images anatomy. The combination enables scans that not only indicate function, e.g., how active a tumor is, but precise localization, e.g., the precise location of that tumor in the body. In addition, CT can be used to correct for the attenuation in SPECT acquisitions. Attenuation in SPECT is an unwanted side effect of the gamma rays scattering and being absorbed by tissue. This can lead to errors in the final image. The CT directly measures attenuation and can be used to create a 3D attenuation map of the patient which can be used to correct the SPECT images. The SPECT-CT scanner can be used to image and track how much dose was delivered to both the target and the surrounding tissue. The systems consist of display equipment, data storage devices, patient and equipment supports and component parts and accessories. Symbia Pro.specta VA30A release is the product name for the addition of features to the approved Symbia Pro.specta VA20A Family (K231102). The Symbia Pro.specta VA30A devices are based on the Symbia Pro.specta VA20A Family. The difference lies in the additional features/changes. The Intended Purpose and fundamental scientific technology remain unchanged. Proposed new features in Symbia Pro.specta VA30 include: - Cardiac Quantification - High Speed Mode - . NM Remote Reconstruction on myExam Satellite #### Other changes: - Scanning improvements - Recon improvements ● - General software improvements ● - Miscellaneous improvements ●

This computed tomography system is intended to generate and process cross-sectional images by computed reconstruction of x-ray transmission data within a 26 cm field-of-view, for the head and neck. The images delivered by the system can be used by a trained staff as an aid in diagnosis.

The SOMATOM On.site with software version syngo CT VB10 is a mobile computed tomography (CT) scanner system that will be offered in two variants: - . SOMATOM On.site for Intensive Care Unit (ICU) Mobile CT scanner affixed to a motorized trolley for use in hospital situations. The scanner can be moved from patient bed to patient bed to perform scanning at the point of care. Although it might be used in other environments like emergency rooms or angiography labs, the main location where this scanner will be used, will be the intensive care unit (ICU). - . SOMATOM On.site for Mobile Stroke Unit (MSU) Mobile CT Scanner that is mounted to the floor of a diagnostic room or vehicle. The system main place where the scanner will be mounted is in a mobile stroke unit (MSU), which is a specific type of ambulance. The subject device SOMATOM On.site with SOMARIS/10 syngo CT VB10 is a mobile Computed Tomography X-ray Systems which features a continuously rotating tube-detector system and function according to the fan beam principle. The SOMATOM On.site with software SOMARIS/10 syngo CT VB10 produces CT images in DICOM format, which can be used by trained staff for postprocessing applications commercially distributed by Siemens Healthcare and other vendors as an aid in diagnosis and treatment preparation. The computer system integrated with the CT scanner is able to run optional post processing applications.