Radiological images; modality varies or is not specified in FDA list radiology AI tools
100 source-backed listings mapped to this modality. Use each profile to verify FDA file number, workflow fit, integration, deployment, and unknown fields.
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Each entry is an FDA submission, not a distinct commercial offer. Inspect the exact record before comparing evidence, asking for a quote or planning an integration.
Which acquisition protocols and input series match the exact labeled scope?
Is the proposed job detection, reading support, quantification, processing or another role?
How will outputs reach the reader, and who will test the installed configuration?
Authorized purpose: ADAS 3D supports visualization and analysis of MR and CT images of the heart for individual patients with cardiovascular disease, including patients with myocardial scar from ischemic or non-ischemic heart disease. Qualified professionals may use it for cardiac calculation, quantification, visualization, pre-planning, and electrophysiology procedures; produced data support clinical decision-making and must not be used as irrefutable medical advice or for radiotherapy planning, dose calculation, or treatment delivery.
Modality
Radiological images; modality varies or is not specified in FDA list
Authorized purpose: Cercare Neurosuite with Capillary Function and Oncology Virtual Expert processes CT or MR information to provide perfusion, tissue-blood-volume, diffusion, labeling, and quantification support for adult brain glioma workflows.
Modality
Radiological images; modality varies or is not specified in FDA list
Synapse PACS 7.6.0 provides medical-image management and processing, including measurements, regional segmentation, clinical calculations, structured reports, comparison, fusion, and volume rendering to aid reading, interpretation, reporting, and treatment planning.
Modality
Radiological images; modality varies or is not specified in FDA list
Authorized purpose: HistoSonics Planning Tool is a stand-alone visualization and comparison tool for CT and MR studies used to plan histotripsy target localization, treatment volume, acoustic path, and patient position.
Modality
Radiological images; modality varies or is not specified in FDA list
Authorized purpose: UNiD Spine Analyzer SW3002 v5.1.0 enables healthcare professionals to view and measure images and plan orthopedic spine surgeries, including preoperative and postoperative measurements and patient-specific rod or implant planning.
Modality
Radiological images; modality varies or is not specified in FDA list
Authorized purpose: Fujifilm Synapse 3D Base Tools V7.2 provides trained professionals with two-dimensional, three-dimensional, multiplanar, and related viewing, measurement, and analysis functions for the supported DICOM studies.
Modality
Radiological images; modality varies or is not specified in FDA list
Anatomy
Whole body and modality-specific anatomy represented in CT, MR, CR, US, NM, PT, and XA studies
Authorized purpose: syngo Dynamics VA41F is a vendor-agnostic cardiology image and information-management system that supports multimodality review, diagnosis, and patient management for the labeled cardiac, vascular, and maternal-fetal workflows.
Modality
Radiological images; modality varies or is not specified in FDA list
Anatomy
Cardiac; vascular; and maternal-fetal medicine anatomy
Authorized purpose: AiORTA - Plan v2.0 is image-processing and analysis software for the labeled radiotherapy-planning workflow; exact modalities, structures, inputs, outputs, and user-review requirements remain submission-specific.
Modality
Radiological images; modality varies or is not specified in FDA list
Authorized purpose: Contour ProtégéAI+ processes CT and MR DICOM images and generates contours for quantitative analysis, adaptive therapy, image registration, transfer to radiotherapy planning, and archiving subject to qualified review and editing.
Modality
Radiological images; modality varies or is not specified in FDA list
Beijing Infervision Healthcare Medical Technology Co., Ltd.
Authorized purpose: InferCare RECIST is a post-processing application for longitudinal medical-image display, lesion measurement, registration, tracking, segmentation, three-dimensional reconstruction, and RECIST reporting by trained professionals.
Modality
Radiological images; modality varies or is not specified in FDA list
Anatomy
Tumors and lesions in adult patients age 21 and older
Authorized purpose: MI View&GO is a medical diagnostic application for viewing, manipulating, quantifying, analyzing, and comparing PET, nuclear-medicine, CT, and MR images across one or more time points, including labeled oncology, cardiology, neurology, organ-function, and radiotherapy-planning workflows.
Modality
Radiological images; modality varies or is not specified in FDA list
Anatomy
Whole body, organs, tumors, heart, brain, and oncology regions
Authorized purpose: Surgical Reality Viewer provides preoperative and intraoperative two-dimensional and three-dimensional visualizations from patient images and normal-anatomy segmentations; machine-learning segmentations are preliminary and require professional review.
Modality
Radiological images; modality varies or is not specified in FDA list
Anatomy
Patient-specific surgical anatomy and normal anatomy
Authorized purpose: Quantitative brain MRI and amyloid-PET analysis, including volumetric reference-percentile comparison and SUVR quantification, to support physician clinical evaluation.
Modality
Radiological images; modality varies or is not specified in FDA list
Authorized purpose: AV Vascular assists trained healthcare professionals with visualization, assessment, and quantification of vascular anatomy on CTA and/or MRA for suspected or diagnosed vascular pathology and pre-procedural endovascular planning.
Modality
Radiological images; modality varies or is not specified in FDA list
Anatomy
Vascular anatomy; head/neck, body, aorta, iliac and subclavian vessels
Authorized purpose: Imagine Enterprise Suite receives, stores, shares, visualizes, quantifies, and processes images from multiple modalities; MPXA-2000 supports coronary-angiography calculation with automated vessel contours that require review and editing.
Modality
Radiological images; modality varies or is not specified in FDA list
Anatomy
Cardiac and coronary anatomy plus multi-modality clinical studies
Authorized purpose: PeekMed web supports preoperative planning from imported patient imaging with two-dimensional and three-dimensional visualization, measurements, templates, and machine-learning-assisted knee segmentation and landmarking subject to clinician review and approval.
Modality
Radiological images; modality varies or is not specified in FDA list
Anatomy
Patient-specific anatomy for preoperative planning, including knee and labeled orthopedic regions
Authorized purpose: IRISeg accepts MR or contrast-enhanced CT images for manual and machine-learning image analysis and segmentation and produces visual three-dimensional models for preoperative planning or intraoperative display; output is non-diagnostic and requires clinician decisions.
Modality
Radiological images; modality varies or is not specified in FDA list
Anatomy
Kidneys and other patient-specific surgical anatomy
Authorized purpose: PeekMed web supports preoperative planning from imported patient imaging with two-dimensional and three-dimensional visualization, measurements, templates, and machine-learning-assisted knee segmentation and landmarking subject to clinician review and approval.
Modality
Radiological images; modality varies or is not specified in FDA list
Anatomy
Patient-specific anatomy for preoperative planning, including knee and labeled orthopedic regions
3mensio Workstation is standalone medical-image analysis software for advanced visualization and quantitative analysis of cardiovascular structures. It supports CT, X-ray angiography, and two- and three-dimensional ultrasound DICOM data for planning and sizing cardiovascular interventions, postoperative evaluation, coronary measurements, and calcium scoring.
Modality
Radiological images; modality varies or is not specified in FDA list
Authorized purpose: Syngo Carbon Clinicals VA41 provides advanced visualization and analysis for clinical images, including OrthoMatic Spine whole-spine curve-angle measurements and TimeLens comparison of regions of interest across time points.
Modality
Radiological images; modality varies or is not specified in FDA list
Anatomy
Whole spine and other clinical image regions represented in supported CT and MR workflows
Authorized purpose: Axial3D Insight is a cloud-based image-segmentation service that transfers DICOM images to generate visual models and physical-replica inputs for trauma, orthopedic, maxillofacial, cardiovascular, and treatment-planning workflows; final decisions require expert review.
Modality
Radiological images; modality varies or is not specified in FDA list
Anatomy
Trauma, orthopedic, maxillofacial, and cardiovascular anatomy
Beijing Infervision Healthcare Medical Technology Co., Ltd.
Authorized purpose: InferOperate Suite supports trained healthcare professionals in reading, interpreting, reporting, and treatment planning from medical images, with the submission's machine-learning functions applied to adult chest, abdomen, and pelvis CT.
Modality
Radiological images; modality varies or is not specified in FDA list
Anatomy
Chest; abdomen; pelvis; and general patient anatomy represented in supported images
Authorized purpose: BioTraceIO Vision V1.7 processes CT and MR images to support ablation target and needle planning and zone confirmation for the labeled liver and kidney workflows.
Modality
Radiological images; modality varies or is not specified in FDA list
Authorized purpose: UNiD Spine Analyzer assists healthcare professionals in viewing and measuring images and planning orthopedic spine surgery, including preoperative and postoperative measurements, surgical-strategy simulation, and patient-specific or standard implant planning; clinical judgment and surgeon validation remain required.
Modality
Radiological images; modality varies or is not specified in FDA list
Authorized purpose: PeekMed is a cloud web system for preoperative orthopedic planning from imported X-ray, CT, and MR images, with two-dimensional and three-dimensional visualization, measurements, and prosthetic templates for adults with injury or disability.
Modality
Radiological images; modality varies or is not specified in FDA list
Anatomy
Hip; knee; upper limb; foot; and other labeled orthopedic anatomy
Authorized purpose: Synapse PACS version 7.5 provides primary processing and presentation of DICOM and supported non-DICOM images with measurement, segmentation, fusion, volume rendering, reporting, integrated 3D, two-point VOI, and AI-assisted bone removal.
Modality
Radiological images; modality varies or is not specified in FDA list
Authorized purpose: TraumaCad Neo assists healthcare professionals in analyzing orthopedic conditions and planning orthopedic procedures by overlaying measurements and prosthesis templates on relevant radiological images; it is not primary radiological interpretation and clinical judgment remains required.
Modality
Radiological images; modality varies or is not specified in FDA list
Anatomy
Hip, knee, upper-limb, and foot orthopedic anatomy represented in X-ray or CT studies
Authorized purpose: Clever One is dental imaging software for trained professionals to view and interpret DICOM images from CT, panoramic, cephalometric, intraoral, and other imaging equipment, with two-dimensional analysis and three-dimensional visualization tools.
Modality
Radiological images; modality varies or is not specified in FDA list
Authorized purpose: Synapse 3D Base Tools assists trained professionals with reading, interpreting, reporting, and treatment planning from DICOM data from CT, MR, CR, US, NM, PT, XA, and other supported modalities; the base tools are not primary mammography interpretation.
Modality
Radiological images; modality varies or is not specified in FDA list
Anatomy
Multi-region anatomy represented in CT, MR, CR, US, NM, PT, and XA studies
Authorized purpose: Triage and prioritization of adult CXR and non-contrast brain CT studies for specified suspected findings, including pneumoperitoneum, pleural effusion, pneumothorax and tension pneumothorax on CXR, and acute extra-axial hemorrhage, subarachnoid hemorrhage, intra-axial hemorrhage, intraventricular hemorrhage, mass effect, obstructive hydrocephalus and vasogenic edema on brain CT.
Modality
Radiological images; modality varies or is not specified in FDA list
Authorized purpose: VersaViewer supports two-dimensional, three-dimensional, and four-dimensional medical-image series processing and analysis through customizable layouts, multimodality review, and measurements for trained healthcare professionals; it is not for displaying digital mammography for diagnosis.
Modality
Radiological images; modality varies or is not specified in FDA list
Anatomy
Multi-region anatomy represented in CT, MR, PET, NM, XA, and other supported studies
Authorized purpose: syngo Dynamics VA41D is a multimodality, vendor-agnostic cardiology image and information system for management, processing, review, post-processing, and quantification of cardiac ultrasound, X-ray angiography, nuclear medicine, CT, MR, vascular ultrasound, and obstetric or fetal studies.
Modality
Radiological images; modality varies or is not specified in FDA list
Anatomy
Cardiac, vascular, obstetric, and fetal anatomy represented in multimodality studies
Authorized purpose: PeekMed web supports preoperative planning from imported patient imaging with two-dimensional and three-dimensional visualization, measurements, templates, and procedure planning; qualified professionals must revise and approve the output using clinical assessment.
Modality
Radiological images; modality varies or is not specified in FDA list
Anatomy
Patient-specific surgical anatomy represented in imported medical imaging
Authorized purpose: CT and MR 3D segmentation, measurements and interactive models for adult preoperative and intraoperative surgical planning; not primary diagnosis.
Modality
Radiological images; modality varies or is not specified in FDA list
Authorized purpose: aiCockpit AI Viewer displays DICOM and AI images with annotations, measurements, three-dimensional reformats, and reports for trained healthcare professionals; the physician retains the final clinical interpretation.
Modality
Radiological images; modality varies or is not specified in FDA list
Anatomy
Multi-region anatomy represented in general-radiology and other healthcare imaging studies
Authorized purpose: QuickRad is a web PACS for radiology centers, diagnostic laboratories, and hospitals to receive, store, transmit, process, and display DICOM medical images; optional cleared third-party AI outputs are displayed as received and require professional review.
Modality
Radiological images; modality varies or is not specified in FDA list
Anatomy
Multi-region anatomy represented in CT, MRI, ultrasound, and X-ray studies
Authorized purpose: Ultrasound Workspace reviews, quantifies, and reports structures and function from multidimensional digital medical data from different modalities in cardiovascular, fetal, and abdominal workflows to support physician diagnosis.
Modality
Radiological images; modality varies or is not specified in FDA list
Anatomy
Cardiovascular, fetal, and abdominal anatomy represented in multidimensional medical data
Authorized purpose: Lightning Viewer is software for diagnostic and clinical review of general-radiology and other healthcare imaging applications. The FDA indication describes review and navigation of diagnostic images with tools for visualization, and use with appropriate displays by trained healthcare professionals.
Modality
Radiological images; modality varies or is not specified in FDA list
Authorized purpose: The OrthoNext Platform System is indicated to assist healthcare professionals in preoperative planning of orthopedic surgery and postoperative planning of orthopedic treatment. It overlays Orthofix product templates on radiological images and provides tools for image measurement and template positioning.
Modality
Radiological images; modality varies or is not specified in FDA list
Authorized purpose: PeekMed web is designed to help healthcare professionals perform preoperative planning for surgical procedures using imported patient imaging studies. The FDA material describes two-dimensional and three-dimensional image representation, measurements, templates, and a database of digital representations of surgical materials supplied by manufacturers.
Modality
Radiological images; modality varies or is not specified in FDA list
Authorized purpose: The LungVision System enables users to segment previously acquired 3D CT datasets and overlay and register those segmented datasets with fluoroscopic live X-ray images of the same anatomy to support catheter or device navigation during pulmonary procedures.
Modality
Radiological images; modality varies or is not specified in FDA list
Authorized purpose: LumiNE converts adult CT or contrast-enhanced T1 MR images into reviewed three-dimensional models and displays two- and three-dimensional images in a browser or Microsoft HoloLens 2 for preoperative planning, not diagnosis.
Modality
Radiological images; modality varies or is not specified in FDA list
Authorized purpose: ADAS 3D provides visualization, analysis, and quantification of MR and CT heart images in individual patients with cardiovascular disease, including myocardial scar assessment for pre-planning and during electrophysiology procedures.
Modality
Radiological images; modality varies or is not specified in FDA list
Anatomy
Heart; myocardial scar and cardiovascular structures
Authorized purpose: MI View&GO is a medical diagnostic application for viewing, manipulating, quantifying, analyzing, and comparing PET, nuclear-medicine, CT, and MR images. The FDA material describes use across labeled oncology, cardiology, neurology, organ-function, and radiotherapy-planning workflows.
Modality
Radiological images; modality varies or is not specified in FDA list
Anatomy
Multi-region PET, nuclear-medicine, CT, and MR studies
Authorized purpose: SIS System fuses clinical brain MRI with postoperative CT to visualize DBS anatomy, localize STN, GPe, GPi, and Vim, and segment implanted leads for surgical review.
Modality
Radiological images; modality varies or is not specified in FDA list
Authorized purpose: Syngo Carbon Enterprise Access is indicated for display and rendering of medical data within healthcare institutions. The FDA summary describes an enterprise web application for DICOM, non-DICOM, multimedia, and clinical documents and standardized generic interfaces that do not control or alter connected medical devices.
Modality
Radiological images; modality varies or is not specified in FDA list
Anatomy
Medical data and clinical images within healthcare institutions
Authorized purpose: Rapid is image-viewing, processing, and analysis software for DICOM CT, CT perfusion, CT angiography, C-arm CT perfusion, and MRI data, including perfusion maps and acute-stroke selection support under the labeled occlusion and imaging criteria.
Modality
Radiological images; modality varies or is not specified in FDA list
Anatomy
Brain, cerebral vasculature, and perfusion regions
Authorized purpose: VisAble.IO is CT and MR image-processing software for liver-ablation procedures. It imports images from CT and MR scanners and facility PACS systems, assists physicians with ablation-target identification and virtual ablation-needle placement, and assists confirmation of ablation zones.
Modality
Radiological images; modality varies or is not specified in FDA list
Anatomy
Liver, hepatic and portal veins, ablation targets, and ablation zones
Authorized purpose: Rapid Platform v6.0 is image-processing software for trained professionals that views, processes, and analyzes DICOM images from CT and MRI. It supports functional and dynamic datasets including CT perfusion, CT angiography, diffusion-weighted MRI, and dynamic contrast-enhanced CT or MRI, with maps and measurements for tissue perfusion, diffusion, and blood volume. Rapid CT-Perfusion and Rapid MR-Perfusion may aid physicians in selecting acute stroke patients with known occlusion of the intracranial internal carotid artery or proximal middle cerebral artery for endovascular thrombectomy, subject to the labeled imaging criteria, clinical requirements, and exclusions.
Modality
Radiological images; modality varies or is not specified in FDA list
Anatomy
Brain and intracranial vessels represented in CT perfusion, CTA, and MRI; tissue perfusion, diffusion, and contrast dynamics
Authorized purpose: uOmnispace.MI is software for viewing, processing, evaluating, and analyzing PET, CT, MR, and SPECT images within healthcare institutions, with labeled applications for multimodality reporting, follow-up registration and lesion segmentation, dynamic PET analysis and time-activity curves, brain PET relative-activity analysis, and cardiac short-axis, perfusion, activity, and function analysis.
Modality
Radiological images; modality varies or is not specified in FDA list
Anatomy
Multi-region PET, CT, MR, and SPECT examinations including oncology, neurology, cardiology, brain, and cardiac analyses
Authorized purpose: Syngo Carbon Clinicals provides advanced visualization tools to prepare and process medical images acquired by modalities such as CT and MR for evaluation, manipulation, communication, qualitative and quantitative measurements, and analysis, with an interface to interconnected image-viewing, communication, and storage software.
Modality
Radiological images; modality varies or is not specified in FDA list
Anatomy
Anatomy represented in CT, MR, and other supported clinical images, including lung lesion workflows
Authorized purpose: Axial3D Insight is a cloud-based service and image-segmentation framework that transfers DICOM imaging information from a medical scanner to an output file for additive-manufactured physical replicas, treatment planning, or diagnostic use in the labeled trauma, orthopedic, maxillofacial, and cardiovascular fields.
Modality
Radiological images; modality varies or is not specified in FDA list
Anatomy
Patient-specific anatomy in trauma, orthopedic, maxillofacial, and cardiovascular applications
Authorized purpose: aprevo Digital Segmentation is software for trained, medically knowledgeable design personnel to perform digital image segmentation of the spine, primarily lumbar anatomy; it inputs DICOM images and outputs a three-dimensional spine model.
Modality
Radiological images; modality varies or is not specified in FDA list
Authorized purpose: HipCheck assists surgeons with quantitative measurements for femoroacetabular-impingement procedures by processing intraoperative static fluoroscopic images and superimposing virtual measurement tools for skeletally mature patients. HipMap FAI Analysis provides a patient-specific report for surgeon or radiologist preoperative decision-making with morphological measurements and visualizations of hip impingement and stability.
Modality
Radiological images; modality varies or is not specified in FDA list
Anatomy
Hip; femoral head and neck; femoroacetabular impingement
Authorized purpose: The OFIX MIS App assists healthcare professionals in viewing, storing, and measuring images and planning orthopedic surgeries, including measurements for placement of surgical implants.
Modality
Radiological images; modality varies or is not specified in FDA list
Anatomy
Patient-specific orthopedic surgical anatomy and implant-placement landmarks
Authorized purpose: uOmnispace is software for viewing, manipulating, communicating, storing, processing, and filming multimodality DICOM images, usable stand-alone or with cleared software options and multi-vendor applications meeting interface requirements; it is not intended to display digital mammography images for diagnosis in the United States.
Modality
Radiological images; modality varies or is not specified in FDA list
Anatomy
Multi-region medical images, excluding U.S. digital mammography diagnosis
Authorized purpose: Brainlab Elements are software applications for processing medical-image data to support image-guided surgery and radiation-treatment planning; the exact submission includes contouring, rigid and deformable image fusion, DTI fiber tracking, task-based BOLD MRI mapping, and cerebrovascular image co-registration.
Modality
Radiological images; modality varies or is not specified in FDA list
Anatomy
Patient medical-image data for image-guided surgery and radiation-treatment planning, including cranial white matter, task-based BOLD MRI, and cerebrovascular data
Authorized purpose: Axial3DInsight is a cloud-based service and image-segmentation framework that transfers DICOM imaging information from a medical scanner to an output file for additive-manufactured physical replicas, treatment planning, or diagnostic use in the labeled orthopedic trauma, orthopedic, maxillofacial, and cardiovascular fields.
Modality
Radiological images; modality varies or is not specified in FDA list
Anatomy
Patient-specific anatomy in orthopedic trauma, orthopedic, maxillofacial, and cardiovascular applications
Authorized purpose: SIS System fuses clinical brain MRI with postoperative CT to visualize DBS anatomy, localize STN, GPe, and GPi, and segment implanted leads for professional review.
Modality
Radiological images; modality varies or is not specified in FDA list
Authorized purpose: Ceevra Reveal 3 processes, reviews, analyzes, communicates, and interchanges multidimensional CT and MR images for preoperative planning and intraoperative display, with preliminary machine-learning segmentations of selected normal anatomy for adult patients aged 22 years and older.
Modality
Radiological images; modality varies or is not specified in FDA list
Anatomy
Patient-specific anatomy represented in CT or MR; normal anatomy used by supported segmentation models
Authorized purpose: RadioLens v1.0 is a medical diagnostic application for displaying, processing, storing, and transferring DICOM data other than mammography, with filtering, digital manipulation, and quantitative measurements; its optional SpindleX module analyzes potential vertebral displacement in adult cervical or lumbar spine stress X-rays and calculates measurements related to spinal-ligament injury leading to subluxation.
Modality
Radiological images; modality varies or is not specified in FDA list
Anatomy
Spine, including cervical and lumbar vertebrae; general DICOM images excluding mammography
Authorized purpose: Aibolit 3D+ processes, reviews, analyzes, communicates, and exchanges multidimensional digital images acquired from CT and MR devices for preoperative surgical planning, training, patient information, and intraoperative display, assisting the clinician responsible for final patient-management decisions.
Modality
Radiological images; modality varies or is not specified in FDA list
Anatomy
Patient-specific anatomy represented in CT and MR images for preoperative or intraoperative planning
Authorized purpose: SIS System version 5.6.0 fuses clinical brain MRI with postoperative CT for DBS anatomy visualization and implanted-lead placement localization, including STN, GPe, and GPi.
Modality
Radiological images; modality varies or is not specified in FDA list
Authorized purpose: Syngo Dynamics VA40F is a multimodality, vendor-agnostic cardiology image and information system for medical-image management and processing, with post-processing functions for image manipulation and quantification supporting interpretation and analysis for disease detection, diagnosis, and patient management within a healthcare institution's network.
Modality
Radiological images; modality varies or is not specified in FDA list
Anatomy
Anatomy represented in multimodality cardiology medical images, excluding U.S. digital mammography diagnosis
Authorized purpose: MI View&GO is a multimodality medical-image application for viewing, manipulating, quantifying, analyzing, and comparing PET, SPECT, CT, and MR images across time points in oncology, cardiology, neurology, organ-function, and radiotherapy-planning workflows.
Modality
Radiological images; modality varies or is not specified in FDA list
Anatomy
Whole body, organs, tumors, heart, brain, and oncology regions
Authorized purpose: Segment 3DPrint reviews and segments images from medical scanners and medical 3D models to generate 3D models for diagnostic visualization, measurement, treatment planning, and additive-manufacturing support in pediatric and adult orthopedic, maxillofacial, and cardiovascular workflows.
Modality
Radiological images; modality varies or is not specified in FDA list
Anatomy
Orthopedic, maxillofacial, cardiovascular, and other patient-specific anatomy represented in medical images
Authorized purpose: Rapid processes CT, CTP, CTA, diffusion MRI, and dynamic-contrast MRI for stroke viewing, perfusion, volumetry, mismatch, and large-vessel-density support for trained professionals.
Modality
Radiological images; modality varies or is not specified in FDA list
Authorized purpose: Qmenta Care Platform Family is the exact FDA-cleared medical-image software submission identified by K202718; use is limited to the modality, anatomy, inputs, outputs, and clinical workflow stated in its FDA decision material, with no broader modality or performance claim promoted here.
Modality
Radiological images; modality varies or is not specified in FDA list
Anatomy
Patient-specific anatomy represented in imported medical images
Authorized purpose: syngo.via MI WorkFlows, Scenium, and syngo MBF support the viewing, processing, and quantitative review of supported molecular-imaging and cardiac studies in the exact K211459 workflow; modality and application limits follow the FDA submission.
Modality
Radiological images; modality varies or is not specified in FDA list
Anatomy
Cardiac, whole-body, and other anatomy represented in supported PET/CT, SPECT, or MR studies
Authorized purpose: SIS System version 5.1.0 processes and fuses brain MRI and CT for DBS surgical planning and visualization of STN, GPe, and GPi anatomy.
Modality
Radiological images; modality varies or is not specified in FDA list
Authorized purpose: Synapse 3D Base Tools is medical-imaging software that provides trained medical professionals tools to aid reading, interpreting, reporting, and treatment planning. It accepts DICOM images from imaging devices including CT, MR, CR, US, NM, PT, and XA, and provides viewing, volume rendering, multiplanar reconstruction, fusion, subtraction, segmentation, measurements, annotations, reporting, image management, and modality-specific CT and MR tools. It is not intended for primary diagnostic interpretation of mammography images.
Modality
Radiological images; modality varies or is not specified in FDA list
Anatomy
Patient anatomy represented in supported DICOM CT, MR, CR, US, NM, PT, and XA images; mammography excluded
Authorized purpose: AI Metrics supports viewing, manipulation, communication, storage, annotation, analysis, and comparison of medical images and anatomical datasets across modalities and timepoints for workflow automation and follow-up documentation in radiology, oncology, and other medical-imaging environments.
Modality
Radiological images; modality varies or is not specified in FDA list
Anatomy
Multimodality medical-image datasets including CT and MR
Authorized purpose: Neuro.Al Algorithm processes static, functional, dynamic, and derived CT or MR images to support brain perfusion analysis, tissue blood-volume and parametric-map review, ventricular visualization, and DICOM return to clinical viewers for trained professional interpretation.
Modality
Radiological images; modality varies or is not specified in FDA list
Authorized purpose: AI-Rad Companion Engine is a software platform that provides basic visualization and enables external post-processing extensions for medical images used for diagnostic purposes. It supports technicians and trained physicians in qualitative and quantitative measurement and analysis, stores data, transfers data to other systems such as PACS, validates DICOM tags, and provides interfaces for clinical extensions.
Modality
Radiological images; modality varies or is not specified in FDA list
Anatomy
Medical images and clinical data represented in multimodality DICOM studies
Authorized purpose: ADAS 3D post-processes contrast cardiac MRI and CTA to visualize and quantify myocardial scar and export reviewed results to electrophysiology navigation systems; it is not intended to identify ablation targets.
Modality
Radiological images; modality varies or is not specified in FDA list
Authorized purpose: MEDIP PRO is a software interface and image-segmentation system for transferring DICOM imaging information from a medical scanner to an output file and for preoperative treatment planning. Three-dimensional printed models generated from the output file are intended for non-diagnostic use, and the software is to be used with other diagnostic tools and expert clinical judgment.
Modality
Radiological images; modality varies or is not specified in FDA list
Anatomy
Anatomy represented in CT or MR DICOM images for preoperative treatment planning
Authorized purpose: Merge PACS is a multi-modality image-management and diagnostic-viewing system for processing, displaying, communicating, reporting, printing, storing, and retrieving supported DICOM and related clinical images for radiologists, surgeons, referring physicians, and other authorized users.
Modality
Radiological images; modality varies or is not specified in FDA list
Authorized purpose: SIS Software v3.6.0 displays, presents, documents, registers, fuses, and processes brain MR and postoperative CT images to support stereotactic neurosurgery and subthalamic-nucleus visualization.
Modality
Radiological images; modality varies or is not specified in FDA list
Authorized purpose: D2P is a software interface and image-segmentation system for transferring DICOM imaging information from a medical scanner to an output file and is also preoperative software for surgical planning. The output may be used to produce a physical replica for adjunctive use with other diagnostic tools and expert clinical judgment in cardiovascular, craniofacial, gastrointestinal, genitourinary, neurological, and musculoskeletal applications.
Modality
Radiological images; modality varies or is not specified in FDA list
Anatomy
Cardiovascular, craniofacial, gastrointestinal, genitourinary, neurological, and musculoskeletal anatomy
Authorized purpose: RayCare is an oncology information system used to support workflows, scheduling, and clinical information management for oncology care and follow-up. It may transfer, store, convert, and display patient data in cancer care including radiation therapy, medical oncology, and surgical oncology. RayCare is not intended for diagnostic activities.
Modality
Radiological images; modality varies or is not specified in FDA list
Anatomy
Patient data across radiation, medical, and surgical oncology care; no diagnostic anatomy
Authorized purpose: SurgicalAR displays CT and MR medical images and associated data as two-dimensional, multiplanar, three-dimensional, or volume-rendered views on a workstation, touchscreen, or head-mounted display to support surgical planning and intraoperative review; headset and mobile views are informational and non-diagnostic.
Modality
Radiological images; modality varies or is not specified in FDA list
Authorized purpose: SIS Software v3.3.0 fuses clinical brain MRI with postoperative CT to visualize and localize the subthalamic nucleus and support stereotactic surgical planning.
Modality
Radiological images; modality varies or is not specified in FDA list
AI-Rad Companion Engine is a Siemens cloud platform for multimodality, multivendor DICOM validation, storage, basic visualization, routing, and integration of optional post-processing extensions.
Modality
Radiological images; modality varies or is not specified in FDA list
Authorized purpose: iSchemaView RAPID processes CT perfusion, CTA, and MR studies to visualize and analyze diffusion and perfusion, including tissue blood-volume maps, and supports physician selection of eligible acute-stroke patients with known intracranial ICA or proximal MCA occlusion for thrombectomy.
Modality
Radiological images; modality varies or is not specified in FDA list
Anatomy
Brain, intracranial vasculature, and perfusion regions
Authorized purpose: Centricity Universal Viewer displays, communicates, stores, and processes supported medical images and related data for authorized users in clinical imaging workflows.
Modality
Radiological images; modality varies or is not specified in FDA list
Authorized purpose: icobrain segments and quantifies brain structures and lesions from MRI or noncontrast CT using cross-sectional and longitudinal workflows with acquisition-consistency limits.
Modality
Radiological images; modality varies or is not specified in FDA list
Authorized purpose: Ziostation2 is customer-hardware image-processing software for viewing, quantifying, manipulating, communicating, printing, and managing many radiological image types, with release-specific tools for lung and bronchoscopy planning, cardiac MR T1 mapping, and other advanced visualization.
Modality
Radiological images; modality varies or is not specified in FDA list
Authorized purpose: QTxI manages and evaluates supported DICOM CT and PET studies, including registration, fusion, region-of-interest contouring, quantitative analysis, and evaluation of quantitative changes in the labeled workflow.
Modality
Radiological images; modality varies or is not specified in FDA list
Authorized purpose: Assists healthcare professionals in viewing and measuring images and planning orthopedic surgeries, including generic and spine-related measurements, surgical planning, and implant-placement measurements.
Modality
Radiological images; modality varies or is not specified in FDA list
Anatomy
Spine and anatomical components used for implant placement.
Authorized purpose: Illumeo is an image-management system for trained professionals, including radiologists. It is a software package used with general-purpose computing hardware to acquire, store, distribute, process, and display images and associated data throughout a clinical environment, including digital image processing, measurement, manipulation, quantification, communication, and storage. It is not to be used for mammography.
Modality
Radiological images; modality varies or is not specified in FDA list
Anatomy
Images and associated data represented in the clinical environment; mammography excluded
Authorized purpose: syngo Application Software provides real-time viewing, image manipulation, 3D visualization, communication, and storage of medical images and data on exchange media for diagnostic viewing, post-processing, and viewing or post-processing during interventional procedures. It may run on a stand-alone workstation, send and receive DICOM data over a network, be deployed on Siemens angiography systems, and be combined with fluoroscopy or radiographic systems for image-guided surgery and interventional cardiology, electrophysiology, oncology, radiology, and neuroradiology.
Modality
Radiological images; modality varies or is not specified in FDA list
Anatomy
Anatomy represented in supported medical images and interventional procedures
Authorized purpose: Assists healthcare professionals in viewing and measuring images and planning orthopedic surgeries, including generic and spine-related measurements, surgical planning, and implant-placement measurements.
Modality
Radiological images; modality varies or is not specified in FDA list
Anatomy
Spine and anatomical components used for implant placement.
Authorized purpose: LungVision segments prior 3D CT and registers and overlays it with live fluoroscopic X-ray of the same anatomy to support catheter and device navigation during pulmonary procedures.
Modality
Radiological images; modality varies or is not specified in FDA list
Anatomy
Pulmonary anatomy and catheter/device navigation targets
Authorized purpose: cvi42 analyzes cardiovascular CT and MRI with MPR, MIP, volume rendering, centerlines, lumen and stenosis measurements, and reporting for qualified professionals.
Modality
Radiological images; modality varies or is not specified in FDA list