Modality
107 source-backed listings mapped to this modality. Use each profile to verify FDA file number, workflow fit, integration, deployment, and unknown fields.
Adas3D Medical S.L.
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...
Cercare Medical A/S
Cercare Neurosuite with Capillary Function and Oncology Virtual Expert processes CT or MR information to provide perfusion, tissue-blood-volume, diffusion, labeling, and...
FUJIFILM Healthcare Americas Corporation
Synapse PACS 7.6.0 provides medical-image management and processing, including measurements, regional segmentation, clinical calculations, structured reports, comparison, fusion,...
HistoSonics, Inc.
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,...
Neurophet., Inc.
Brain MRI/PET registration, segmentation and quantitative PET assessment
Medicrea International S.A.S. (Medtronic)
UNiD Spine Analyzer SW3002 v5.1.0 enables healthcare professionals to view and measure images and plan orthopedic spine surgeries, including preoperative and postoperative...
Fujifilm Corporation
Fujifilm Synapse 3D Base Tools V7.2 provides trained professionals with two-dimensional, three-dimensional, multiplanar, and related viewing, measurement, and analysis functions...
Siemens Medical Solutions USA, Inc.
Medical-image viewing and post-processing for diagnosis, interventional treatment planning and treatment control.
Relu BV
Relu Cloud manages, transfers, analyzes, displays, enhances, and stores oral and maxillofacial images and provides design input for dental solutions.
Siemens Healthcare GmbH
syngo Dynamics VA41F is a vendor-agnostic cardiology image and information-management system that supports multimodality review, diagnosis, and patient management for the labeled...
ViTAA Medical Solutions, Inc.
AiORTA - Plan v2.0 is image-processing and analysis software for the labeled radiotherapy-planning workflow; exact modalities, structures, inputs, outputs, and user-review...
Mim Software, Inc.
Contour ProtégéAI+ processes CT and MR DICOM images and generates contours for quantitative analysis, adaptive therapy, image registration, transfer to radiotherapy planning, and...
Beijing Infervision Healthcare Medical Technology Co., Ltd.
InferCare RECIST is a post-processing application for longitudinal medical-image display, lesion measurement, registration, tracking, segmentation, three-dimensional...
Siemens Medical Solutions USA, Inc.
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...
Medicalvr B.V.
Surgical Reality Viewer provides preoperative and intraoperative two-dimensional and three-dimensional visualizations from patient images and normal-anatomy segmentations;...
Neurophet., Inc.
Quantitative brain MRI and amyloid-PET analysis, including volumetric reference-percentile comparison and SUVR quantification, to support physician clinical evaluation.
Philips Medical Systems Nederland B.V.
AV Vascular assists trained healthcare professionals with visualization, assessment, and quantification of vascular anatomy on CTA and/or MRA for suspected or diagnosed vascular...
Softlink International Private Limited
Imagine Enterprise Suite receives, stores, shares, visualizes, quantifies, and processes images from multiple modalities; MPXA-2000 supports coronary-angiography calculation with...
Peek Health, S.A.
PeekMed web supports preoperative planning from imported patient imaging with two-dimensional and three-dimensional visualization, measurements, templates, and...
Intuitive Surgical, Inc.
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...
Peek Health, S.A.
PeekMed web supports preoperative planning from imported patient imaging with two-dimensional and three-dimensional visualization, measurements, templates, and...
Pie Medical Imaging BV
3mensio Workstation is standalone medical-image analysis software for advanced visualization and quantitative analysis of cardiovascular structures. It supports CT, X-ray...
Siemens Healthineers AG
Syngo Carbon Clinicals VA41 provides advanced visualization and analysis for clinical images, including OrthoMatic Spine whole-spine curve-angle measurements and TimeLens...
Axial Medical Printing Limited
Axial3D Insight is a cloud-based image-segmentation service that transfers DICOM images to generate visual models and physical-replica inputs for trauma, orthopedic,...
Beijing Infervision Healthcare Medical Technology Co., Ltd.
InferOperate Suite supports trained healthcare professionals in reading, interpreting, reporting, and treatment planning from medical images, with the submission's...
Techsomed Medical Technologies
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.
Arterys, Inc.
FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....
Medicrea International S.A.S. (Medtronic)
UNiD Spine Analyzer assists healthcare professionals in viewing and measuring images and planning orthopedic spine surgery, including preoperative and postoperative measurements,...
Peek Health, S.A.
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,...
FUJIFILM Healthcare Americas Corporation
Synapse PACS version 7.5 provides primary processing and presentation of DICOM and supported non-DICOM images with measurement, segmentation, fusion, volume rendering, reporting,...
Brainlab Ltd.
TraumaCad Neo assists healthcare professionals in analyzing orthopedic conditions and planning orthopedic procedures by overlaying measurements and prosthesis templates on...
Roche Molecular Systems, Inc.
FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....
Ewoosoft Co., Ltd
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...
FUJIFILM Corporation
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...
GE Medical Systems SCS
VersaViewer supports two-dimensional, three-dimensional, and four-dimensional medical-image series processing and analysis through customizable layouts, multimodality review, and...
Siemens Healthcare GmbH
syngo Dynamics VA41D is a multimodality, vendor-agnostic cardiology image and information system for management, processing, review, post-processing, and quantification of cardiac...
Peek Health, S.A.
PeekMed web supports preoperative planning from imported patient imaging with two-dimensional and three-dimensional visualization, measurements, templates, and procedure planning;...
Ceevra, Inc.
FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....
Fovia, Inc.
aiCockpit AI Viewer displays DICOM and AI images with annotations, measurements, three-dimensional reformats, and reports for trained healthcare professionals; the physician...
Aikenist Technologies Pvt Ltd
QuickRad is a web PACS for radiology centers, diagnostic laboratories, and hospitals to receive, store, transmit, process, and display DICOM medical images; optional cleared...
Philips Ultrasound LLC
Ultrasound Workspace reviews, quantifies, and reports structures and function from multidimensional digital medical data from different modalities in cardiovascular, fetal, and...
Nexsys Electronics Inc. dba Medweb
Lightning Viewer is software for diagnostic and clinical review of general-radiology and other healthcare imaging applications. The FDA indication describes review and navigation...
Orthofix Srl
The OrthoNext Platform System is indicated to assist healthcare professionals in preoperative planning of orthopedic surgery and postoperative planning of orthopedic treatment. It...
Peek Health, S.A.
PeekMed web is designed to help healthcare professionals perform preoperative planning for surgical procedures using imported patient imaging studies. The FDA material describes...
Circle Cardiovascular Imaging Inc.
FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....
BodyVision Medical Ltd.
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...
Augmedit B.V.
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...
Adas3D Medical S.L
ADAS 3D provides visualization, analysis, and quantification of MR and CT heart images in individual patients with cardiovascular disease, including myocardial scar assessment for...
AIQ Global, Inc.
FDA product code LLZ identifies this device class as System, Image Processing, Radiological. Consult the linked FDA record for the exact authorized indications for use.
Siemens Medical Solutions USA, Inc.
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...
Surgical Information Sciences, Inc.
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.
Siemens Healthcare GmbH
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...
iSchema View Inc.
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...
Techsomed
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...
inHEART, SAS
FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....
iSchemaView, Inc.
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...
Shanghai United Imaging Healthcare Co., Ltd.
uOmnispace.MI is software for viewing, processing, evaluating, and analyzing PET, CT, MR, and SPECT images within healthcare institutions, with labeled applications for...
Ceevra, Inc.
FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....
Siemens Healthcare GmbH
Syngo Carbon Clinicals provides advanced visualization tools to prepare and process medical images acquired by modalities such as CT and MR for evaluation, manipulation,...
Axial Medical Printing Limited
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...
Carlsmed, Inc.
aprevo Digital Segmentation is software for trained, medically knowledgeable design personnel to perform digital image segmentation of the spine, primarily lumbar anatomy; it...
Stryker Corp.
HipCheck assists surgeons with quantitative measurements for femoroacetabular-impingement procedures by processing intraoperative static fluoroscopic images and superimposing...
Orthofix US LLC
The OFIX MIS App assists healthcare professionals in viewing, storing, and measuring images and planning orthopedic surgeries, including measurements for placement of surgical...
Shanghai United Imaging Healthcare Co., Ltd
uOmnispace is software for viewing, manipulating, communicating, storing, processing, and filming multimodality DICOM images, usable stand-alone or with cleared software options...
Brainlab AG
Brainlab Elements 6.0 processes medical-image data for image-guided surgery and radiation-treatment planning, including contouring, rigid or deformable image fusion, cranial...
Axial Medical Printing Limited
Axial3DInsight is a cloud-based service and image-segmentation framework that transfers DICOM imaging information from a medical scanner to an output file for...
Surgical Information Sciences, Inc.
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.
Ceevra, Inc.
Ceevra Reveal 3 processes, reviews, analyzes, communicates, and interchanges multidimensional CT and MR images for preoperative planning and intraoperative display, with...
Synapsica
RadioLens v1.0 is a medical diagnostic application for displaying, processing, storing, and transferring DICOM data other than mammography, with filtering, digital manipulation,...
Aibolit Technologies, LLC
Aibolit 3D+ processes, reviews, analyzes, communicates, and exchanges multidimensional digital images acquired from CT and MR devices for preoperative surgical planning, training,...
Surgical Information Sciences, Inc.
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.
Siemens Medical Solutions USA, Inc.
Syngo Dynamics VA40F is a multimodality, vendor-agnostic cardiology image and information system for medical-image management and processing, with post-processing functions for...
Siemens Medical Solutions USA, Inc.
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...
TeraRecon, Inc
FDA product code LLZ identifies this device class as System, Image Processing, Radiological. Consult the linked FDA record for the exact authorized indications for use.
Circle Cardiovascular Imaging Inc
FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....
Medviso AB
Segment 3DPrint reviews and segments images from medical scanners and medical 3D models to generate 3D models for diagnostic visualization, measurement, treatment planning, and...
iSchema View Inc.
Rapid processes CT, CTP, CTA, diffusion MRI, and dynamic-contrast MRI for stroke viewing, perfusion, volumetry, mismatch, and large-vessel-density support for trained...
Change Healthcare Canada Company
FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....
Mint Labs, Inc., d/b/a. QMENTA
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...
Siemens Medical Solutions USA, Inc.
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...
Surgical Information Sciences, Inc.
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.
Fujifilm Corporation
Synapse 3D Base Tools is medical-imaging software that provides trained medical professionals tools to aid reading, interpreting, reporting, and treatment planning. It accepts...
AI Metrics, LLC
AI Metrics supports viewing, manipulation, communication, storage, annotation, analysis, and comparison of medical images and anatomical datasets across modalities and timepoints...
TeraRecon, Inc.
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,...
Siemens Medical Solutions USA, Inc.
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....
Bay Labs, Inc.
Acquisition guidance/quality control
Galgo Medical S.L
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...
MEDICALIP Co., Ltd
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...
Merge Healthcare Incorporated
Merge PACS processes, displays, communicates, reports, prints, stores, and retrieves supported multi-modality DICOM and related clinical images for diagnostic-reading and...
Surgical Information Sciences, Inc.
SIS Software v3.6.0 displays, presents, documents, registers, fuses, and processes brain MR and postoperative CT images to support stereotactic neurosurgery and...
3D Systems, Inc.
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...
TeraRecon Inc.
FDA product code LLZ identifies this device class as System, Image Processing, Radiological. Consult the linked FDA record for the exact authorized indications for use.
RaySearch Laboratories AB (publ)
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,...
MEDIVIS, Inc.
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...
Surgical Information Sciences, Inc.
SIS Software v3.3.0 fuses clinical brain MRI with postoperative CT to visualize and localize the subthalamic nucleus and support stereotactic surgical planning.
Siemens Medical Solutions USA, Inc.
AI-Rad Companion Engine VA10A is a Siemens cloud software platform for multimodality, multivendor DICOM validation, storage, visualization, routing, and integration of optional...
iSchemaView, Inc.
iSchemaView RAPID processes CT perfusion, CTA, and MR studies to visualize and analyze diffusion and perfusion, including tissue blood-volume maps, and supports physician...
GE Healthcare
Centricity Universal Viewer displays, communicates, stores, and processes supported medical images and related data for authorized users in clinical imaging workflows;...
icometrix NV
icobrain segments and quantifies brain structures and lesions from MRI or noncontrast CT using cross-sectional and longitudinal workflows with acquisition-consistency limits.
Arterys Inc.
FDA product code LLZ identifies this device class as System, Image Processing, Radiological. Consult the linked FDA record for the exact authorized indications for use.
Ziosoft, Inc.
Ziostation2 is customer-hardware image-processing software for viewing, quantifying, manipulating, communicating, printing, and managing many radiological image types, with...
AIQ Solutions, Inc.
QTxI manages and evaluates supported DICOM CT and PET studies, including registration, fusion, region-of-interest contouring, quantitative analysis, and evaluation of quantitative...
Philips Medical Systems Technologies, Ltd.
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,...
Infinitt Healthcare Co.,Ltd.
Infinitt PACS 7.0 device is PACS software capable of viewing and handling DICOM 3.x medical images. The System allows displaying of images and image studies that may not in the...
Siemens Medical Solutions, USA, Inc.
syngo Application Software provides real-time viewing, image manipulation, 3D visualization, communication, and storage of medical images and data on exchange media for diagnostic...
BODY VISION MEDICAL LTD.
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...
CIRCLE CARDIOVASCULAR IMAGING INC
cvi42 analyzes cardiovascular CT and MRI with MPR, MIP, volume rendering, centerlines, lumen and stenosis measurements, and reporting for qualified professionals.