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...
Modality
Radiological images; modality varies or is not specified in FDA list
RadOncAI provides AI-guided dose prediction from CT simulation and clinician-defined treatment-planning structures for adult head-and-neck malignant or benign disease.
DeepBT Detector-Plus provides initial gross-tumor-volume contours on T1-weighted contrast-enhanced and optional T2-weighted MR images for radiation-treatment planning in adults...
Modality
Radiotherapy Planning Imaging
Anatomy
Brain tumors, including metastases, meningiomas, and acoustic neuromas
AI-Rad Companion Organs RT VA70 automatically contours predefined structures, including known diagnosed brain metastases, on DICOM CT and MR images for radiation therapy planning;...
Modality
Radiotherapy Planning Imaging
Anatomy
Head/neck, thorax, abdomen, pelvis; MR brain and male pelvis
AiORTA - Plan v2.0 is image-processing and analysis software for the labeled radiotherapy-planning workflow; exact modalities, structures, inputs, outputs, and user-review...
Modality
Radiological images; modality varies or is not specified in FDA list
Contour ProtégéAI+ processes CT and MR DICOM images and generates contours for quantitative analysis, adaptive therapy, image registration, transfer to radiotherapy planning, and...
Modality
Radiological images; modality varies or is not specified in FDA list
AutoContour Model RADAC V5 assists radiation treatment planners with contouring and reviewing structures in medical images for radiation therapy treatment planning. It produces...
syngo.via RT Image Suite VC10 provides three-dimensional and four-dimensional multimodality visualization, registration, fusion, contouring, and planning support for...
Modality
Radiotherapy Planning Imaging
Anatomy
Brain, pelvis, thorax, abdomen, targets, organs at risk, and moving tumors or organs
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...
Modality
Radiological images; modality varies or is not specified in FDA list
Anatomy
Whole body, organs, tumors, heart, brain, and oncology regions
Seg Pro V3 generates initial organ-at-risk contours on DICOM images for radiation-treatment planning by radiation oncologists, medical physicists, and dosimetrists; the contours...
Modality
Radiotherapy Planning Imaging
Anatomy
Head, neck, brain, thorax, abdomen, pelvis, and other labeled radiation-treatment regions
AccuContour 4.0 uses deep-learning contours to support segmentation of organs at risk on CT images for radiation-treatment planning, evaluation, and adaptation; qualified...
Modality
Radiotherapy Planning Imaging
Anatomy
Head and neck, thorax, abdomen, and pelvis organs at risk
The EMLA family delivers external-beam radiation therapy for adult and pediatric patients with benign, malignant, or metastatic disease. Authorized techniques vary by model:...
ART-Plan+ assists trained radiation-therapy professionals with multimodal image review, registration, contouring, and the release-specific planning functions described in K253091....
ARTAssistant supports image registration and synthetic CT generation for adaptive radiation-treatment planning, evaluation, and adaptation from labeled MRI and treatment-planning...
Modality
Radiotherapy Planning Imaging
Anatomy
Head, neck, brain, body, and radiation-treatment structures
Dose+ 1.0 uses locked machine-learning models to predict a patient-specific three-dimensional dose distribution for men receiving external-beam radiotherapy for localized prostate...
uMI Panvivo and Panvivo S acquire and display PET and CT information for anatomical and functional imaging, radiopharmaceutical distribution, and the labeled oncology, cardiology,...
Modality
PET/SPECT/Nuclear Medicine
Anatomy
Whole body; brain; head and neck; heart; lung; breast; gastrointestinal; urinary; genital; and musculoskeletal anatomy
RT Elements is intended to assist in stereotactic, conformal, computer-planned, and linear-accelerator-based radiation treatment planning for cranial, head-and-neck, and...
RayStation and RayPlan releases covered by K240398 are configurable radiotherapy and medical-oncology software that proposes or supports treatment plans from user inputs, with...
AI-Rad Companion Organs RT VA60 automatically contours predefined CT and MR structures for qualified review and DICOM RTSTRUCT transfer into treatment planning; this release added...
ART-Plan+ v3.0.0 assists trained radiation therapy professionals with reviewed CT and MR contour generation and automatic prostate treatment-plan generation for import into a...
OncoStudio OS-01 creates initial deep-learning organs-at-risk contours from CT images of the head and neck, thorax, abdomen, and pelvis for radiation-oncology review, editing, and...
Contour ProtégéAI+ automatically creates contours on CT and T2 MR DICOM images as an accessory to MIM software for quantitative analysis, adaptive therapy, transfer, and archive;...
Modality
Radiotherapy Planning Imaging
Anatomy
CT anatomical regions; prostate, seminal vesicles, and urethra on T2 MR
The uMI Panvivo PET/CT system provides anatomical and functional images. PET depicts the distribution of approved radiopharmaceuticals and CT provides diagnostic tomographic and...
Modality
PET/SPECT/Nuclear Medicine
Anatomy
Whole body and regional anatomy represented in PET/CT studies
AutoContour Model RADAC V4 assists radiation treatment planners with contouring and reviewing structures in CT or MR images for radiation therapy treatment planning. It generates...
Contour+ generates initial CT and MR anatomical contours across head and neck, brain, breast, thoracoabdominal, and pelvic radiation-treatment planning workflows for qualified...
Limbus Contour v1.8.0 assists trained radiation oncologists, dosimetrists, and physicists by generating CT and MR anatomical contours locally on Windows systems for review and...
syngo.via MI Workflows, Scenium, and syngo MBF provide trained healthcare professionals with viewing, manipulation, quantification, analysis, and comparison of PET or...
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...
Modality
Radiological images; modality varies or is not specified in FDA list
Anatomy
Multi-region PET, nuclear-medicine, CT, and MR studies
The uMI Panvivo is a PET/CT system for anatomical and functional images. PET provides distribution information for approved radiopharmaceuticals and CT provides diagnostic...
Modality
PET/SPECT/Nuclear Medicine
Anatomy
Whole body and regional anatomy represented in PET/CT studies
DeepContour uses deep-learning CT processing to generate editable organ contours and RTSTRUCT objects for selected adult radiation-treatment planning workflows, with quantitative...
Ethos Treatment Management 3.0 and Treatment Planning 2.0 manage radiotherapy sessions and create or modify traditional and adapted treatment plans for qualified professional...
AI-Rad Companion Organs RT VA50 automatically contours predefined CT and MR structures for qualified review and DICOM RTSTRUCT transfer into treatment planning; the added MR...
QOCA image Smart RT Contouring System automatically contours DICOM CT imaging data using deep-learning algorithms. Generated contours may be used as input to external-beam...
Modality
Radiotherapy Planning Imaging
Anatomy
Adult patient anatomy represented in CT images and radiation-treatment structures
The Biograph VK10 combines X-ray CT and PET to register and fuse anatomic and physiologic information, supports independent CT or PET imaging, and aids trained professionals in...
Modality
PET/SPECT/Nuclear Medicine
Anatomy
Whole body, cardiovascular, neurological, oncologic, and organ-function imaging
ART-Plan v2.1.0 assists trained radiation therapy professionals with multimodality contouring and registration, synthetic CT from MR or CBCT, dose computation, and CBCT-based...
Contour ProtegeAI assists trained medical professionals with automated processing of CT and MR images, creates machine-learning contours for quantitative analysis, adaptive...
Modality
Radiotherapy Planning Imaging
Anatomy
CT anatomic locations and the prostate, seminal vesicles, and urethra on T2-weighted MR
EFAI HCAPSeg assists trained radiation-oncology professionals with radiation-treatment planning by providing initial deep-learning contours of organs at risk on non-contrast CT...
Modality
Radiotherapy Planning Imaging
Anatomy
Adult organs at risk on non-contrast CT during radiation-treatment planning
The Biograph Vision.X and Biograph Vision.X Edge combine X-ray CT and PET to register and fuse anatomic and physiologic information, support independent CT or PET imaging, aid...
Modality
PET/SPECT/Nuclear Medicine
Anatomy
Whole body, cardiovascular, neurological, oncologic, and organ-function imaging
The MOZI Treatment Planning System is used to plan radiotherapy treatments for patients with malignant or benign diseases and is used to plan external-beam irradiation with photon...
Modality
Radiotherapy Planning Imaging
Anatomy
Patient anatomy represented in external-beam photon-treatment plans
Auto Segmentation generates initial DICOM RT Structure Set contours for 40 organs or subregions from adult contrast or noncontrast CT across head and neck, thorax, abdomen, and...
ART-Plan v1.10.1 assists trained radiation therapy professionals with multimodality registration and reviewed CT or MR contouring; this release added 48 structures to existing...
AutoContour Model RADAC V3 assists radiation treatment planners with reviewed CT and MR contour generation, DICOM RT Structure Set export, and rigid or deformable registration;...
Limbus Contour assists trained radiation oncologists, dosimetrists, and physicists by generating CT and MR healthy-anatomy contours on Windows systems for review and DICOM RT...
Contour ProtegeAI assists trained medical professionals with automated processing of CT and MR images, machine-learning contour creation for quantitative analysis, adaptive...
Modality
Radiotherapy Planning Imaging
Anatomy
CT anatomic locations and the prostate, seminal vesicles, and urethra on T2-weighted MR
RayStation 12A is configurable software for radiation therapy and medical oncology that proposes treatment plans from user input. Authorized users may use reviewed and approved...
AccuContour generates and supports editing of organ-at-risk contours from multimodality imaging, including noncontrast CT, for radiation-treatment planning, evaluation, and...
AVIEW RT ACS is a medical image-management and processing system for radiation-treatment planning with deep-learning auto-segmentation evidence described in the exact FDA decision...
Modality
Radiotherapy Planning Imaging
Anatomy
Organs at risk across breast, head and neck, abdomen, and pelvis CT validation cases, including lung, heart, eyes, brain, mandible, kidneys, liver, femur, and bladder
MRI Planner creates synthetic CT images for photon external-beam radiation planning from MRI and can generate healthy-structure contours for specified brain, head-and-neck, and...
AutoContour Model RADAC V2 assists radiation treatment planners with reviewed CT and MR contour generation, DICOM RT Structure Set export, and rigid or deformable registration;...
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...
Modality
Radiological images; modality varies or is not specified in FDA list
Anatomy
Whole body, organs, tumors, heart, brain, and oncology regions
MVision AI Segmentation automatically generates initial contours from CT images for radiotherapy planning; the contours are transferred for professional visualization, review,...
Modality
Radiotherapy Planning Imaging
Anatomy
Head and neck, brain, breast, lung and abdomen, male pelvis, and female pelvis structures
EFAI RTSuite CT HN-Segmentation System automatically delineates head-and-neck organs at risk on adult non-contrast CT images to support radiation-treatment workflows; initial...
INT Contour uses a machine-learning approach to provide initial segmentation and contouring of treatment targets and organs at risk for radiation-treatment planning; qualified...
FDA product code MUJ identifies this device class as System, Planning, Radiation Therapy Treatment. Consult the linked FDA record for the exact authorized indications for use.
RT-Mind-AI provides the cleared radiotherapy image-processing and treatment-planning support described in K213155 for the labeled anatomy and workflow; generated or processed...
Modality
Radiotherapy Planning Imaging
Anatomy
Head and neck, thorax, abdomen, pelvis, and other labeled radiotherapy regions
Advanced Algorithms for Treatment Management Applications provides the cleared radiotherapy treatment-management functions described in K212218 for supported treatment-planning...
Modality
Radiotherapy Planning Imaging
Anatomy
Patient anatomy represented in external-beam radiation-treatment plans
Contour ProtegeAI creates initial contours from supported radiotherapy images to support treatment planning and related analysis; qualified radiation professionals must review,...
Modality
Radiotherapy Planning Imaging
Anatomy
Head, neck, thorax, abdomen, pelvis, and other labeled radiotherapy structures
VBrain-OAR provides the cleared image-processing and organ-at-risk contouring support described in K212116 for brain radiotherapy planning, with all contours requiring...
AI Segmentation version 2.0 is a cloud web application that generates initial CT organ-at-risk contours for head and neck, thorax, abdomen, and pelvis for review, editing, and...
Vereos PET/CT detects, localizes, diagnoses, stages, restages, and follows treatment response in oncology, cardiology, and neurology and can provide diagnostic CT and...
RayStation 10.1 is configurable radiation-treatment planning software for radiation therapy and medical oncology that supports treatment-plan proposal, review, approval, and...
Automatic Anatomy Recognition is cloud software that generates initial organ-at-risk contours from adult noncontrast CT of the head, neck, and thorax for transfer to a third-party...
AI Segmentation version 1.0 is a static, cloud-hosted web application that generates initial CT organ-at-risk contours for head and neck, thorax, abdomen, and pelvis for review...
DV. Target provides the cleared radiotherapy target or structure image-processing support described in K202928 for supported treatment-planning images and plans under qualified...
Modality
Radiotherapy Planning Imaging
Anatomy
Patient anatomy represented in radiation-treatment images and plans
VBrain assists trained professionals in radiation-treatment planning by providing initial contours of known or diagnosed brain tumors on axial contrast-enhanced T1 brain MR images...
Oncospace supports trained radiation therapy professionals with protocol configuration, achievable-dose prediction, planning-objective exchange, and plan review for prostate,...
ART-Plan assists trained radiation therapy professionals with DICOM CT, MR, and PET image visualization, rigid and deformable registration, and automatic or assisted contouring...
syngo.via molecular-imaging workflows provide viewing, manipulation, quantification, analysis, and comparison of medical images from one or more modalities and time points,...
Modality
PET/SPECT/Nuclear Medicine
Anatomy
Whole-body, cardiac, neurologic, oncologic, organ-function, and radiotherapy-planning anatomy represented in PET, nuclear-medicine, CT, and MR studies
AI-Rad Companion Organs RT VA20 automatically contours predefined organs at risk from adult DICOM CT for qualified review, editing, and DICOM RTSTRUCT transfer into...
AutoContour assists radiation treatment planners by generating initial CT structure contours through a cloud service for review, editing, and DICOM RT Structure Set export to...
RayStation 9.1 and 9.2, marketed as RayStation 9B and 9B SP1, are configurable radiation therapy treatment-planning and analysis software for trained, clinically qualified...
Limbus Contour assists trained radiation oncologists, dosimetrists, and physicists by generating CT and MR anatomical contours for review and DICOM RT Structure Set transfer into...
Contour ProtegeAI is used by trained medical professionals as a tool for automated processing of CT and MR medical images. It creates contours with machine-learning algorithms for...
Modality
Radiotherapy Planning Imaging
Anatomy
Normal structures in CT anatomy; prostate, seminal vesicles, and urethra on T2-weighted MR
AccuContour generates initial organ-at-risk contours from supported multimodality images for physician review in radiation-treatment planning and evaluation workflows.
Biograph Vision and Biograph mCT are combined PET/CT systems for acquiring, reconstructing, fusing, displaying, evaluating, and archiving PET and CT studies across labeled...
Ethos Treatment Management is indicated for managing and monitoring radiation-therapy treatment plans and sessions. Ethos Treatment Planning is indicated for generating and...
Modality
Radiotherapy Planning Imaging
Anatomy
Lesions, tumors, and conditions anywhere in the body; radiation-treatment plans and sessions
FDA product code MUJ identifies this device class as System, Planning, Radiation Therapy Treatment. Consult the linked FDA record for the exact authorized indications for use.
Workflow Box is a software system for routing DICOM-compliant data to and from automated processing components. It supports atlas-based contouring, deformable-image-registration...
Modality
Radiotherapy Planning Imaging
Anatomy
CT, MR, and RTSTRUCT imaging data for automated contours and radiotherapy planning
Microsoft Radiomics App v1.0 is a software-only medical device for trained radiation oncologists, dosimetrists, and physicists to derive organ and tumor contours for...
Modality
Radiotherapy Planning Imaging
Anatomy
CT and MR images; tumors and healthy anatomical structures for radiotherapy planning