FDA-cleared K253969

ADAS 3D

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...

Modality
Radiological images; modality varies or is not specified in FDA list
Anatomy
Heart; myocardial scar and cardiac structures
Decision
2026-06-29
FDA-cleared K253050

RadOncAI

Informai

RadOncAI provides AI-guided dose prediction from CT simulation and clinician-defined treatment-planning structures for adult head-and-neck malignant or benign disease.

Modality
Radiotherapy Planning Imaging
Anatomy
Head and neck
Decision
2026-06-18
FDA-cleared K252190

DeepBT Detector-Plus

Aitewan Biomedical Technology, Inc.

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
Decision
2026-04-10
FDA-cleared K252548

AI-Rad Companion Organs RT

Siemens Healthcare GmbH

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
Decision
2026-04-10
FDA-cleared K254207

AiORTA - Plan v2.0

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...

Modality
Radiological images; modality varies or is not specified in FDA list
Anatomy
Multi-region
Decision
2026-03-30
FDA-cleared K253270

Contour ProtégéAI+

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...

Modality
Radiological images; modality varies or is not specified in FDA list
Anatomy
Multi-region
Decision
2026-03-27
FDA-cleared K260509

AutoContour (RADAC V5)

Radformation, Inc.

AutoContour Model RADAC V5 assists radiation treatment planners with contouring and reviewing structures in medical images for radiation therapy treatment planning. It produces...

Modality
Radiotherapy Planning Imaging
Anatomy
Multi-region
Decision
2026-03-19
FDA-cleared K252304

syngo.via RT Image Suite VC10

Varian Medical Systems, Inc.

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
Decision
2026-03-18
FDA-cleared K252002

Monaco RTP System (6.3)

Elekta Solutions AB

Monaco RTP 6.3 creates external-beam radiation-treatment plans, calculates photon, electron, and proton dose distributions, and supports contouring, image fusion, optimization,...

Modality
Radiotherapy Planning Imaging
Anatomy
Patient anatomy represented in external-beam radiation-treatment plans
Decision
2026-02-19
FDA-cleared K254016

MI View&GO

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...

Modality
Radiological images; modality varies or is not specified in FDA list
Anatomy
Whole body, organs, tumors, heart, brain, and oncology regions
Decision
2026-02-10
FDA-cleared K251306

Seg Pro V3 (RT-300)

Ever Fortune.Ai, Co., Ltd.

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
Decision
2026-01-28
FDA-cleared K251351

AccuContour 4.0

Manteia Technologies Co., Ltd.

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
Decision
2026-01-23
FDA-cleared K253091

ART-Plan+ (v3.1.0)

Therapanacea Sas

ART-Plan+ assists trained radiation-therapy professionals with multimodal image review, registration, contouring, and the release-specific planning functions described in K253091....

Modality
Radiotherapy Planning Imaging
Anatomy
Multi-region
Decision
2025-12-23
FDA-cleared K250780

ARTAssistant

Manteia Technologies Co., Ltd.

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
Decision
2025-12-05
FDA-cleared K250064

Dose+ (1.0)

Mvision AI Oy

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...

Modality
Radiotherapy Planning Imaging
Anatomy
Prostate/Pelvis
Decision
2025-09-04
FDA-cleared K251839

uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S)

Shanghai United Imaging Healthcare Co., Ltd.

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
Decision
2025-07-17
FDA-cleared K250440

RT Elements (4.5); (Elements) Multiple Brain Mets SRS; (Elements) Cranial SRS; (Elements) Spine SRS; (Elements) Cranial SRS w/ Cones; (Elements) RT Planning Platform; (Elements) Dose Review; (Elements) Retreatment Review; Elements Segmentation [Cranial, Basal Ganglia, Head & Neck, Pelvic, Spine, Thoracic & Spine, Extracranial] RT; Elements AI Tumor Segmentation RT; Elements SmartBrush [Angio, Spine] RT; Elements Object Management RT

Brainlab AG

RT Elements is intended to assist in stereotactic, conformal, computer-planned, and linear-accelerator-based radiation treatment planning for cranial, head-and-neck, and...

Modality
Radiotherapy Planning Imaging
Anatomy
Cranial, head-and-neck, and extracranial lesions
Decision
2025-06-17
FDA-cleared K243633

Brainlab Elements (7.0); Brainlab Elements Image Fusion (5.0); Brainlab Elements Image Fusion Angio (1.0); Brainlab Elements Contouring (5.0); Brainlab Elements Fibertracking (3.0); Brainlab Elements BOLD MRI Mapping (1.0)

Brainlab AG

Brainlab Elements Image Fusion, Image Fusion Angio, Fibertracking, Contouring, and BOLD MRI Mapping support co-registration, white-matter visualization, structure outlining, and...

Modality
Radiotherapy Planning Imaging
Anatomy
Cranial, cerebrovascular, and extracranial anatomy
Decision
2025-06-13
FDA-cleared K250427

TAIMedImg DeepMets

Taiwan Medical Imaging Co., Ltd.

TAIMedImg DeepMets assists trained professionals by providing initial gross-tumor-volume contours on axial contrast-enhanced T1 brain MR images for radiation-treatment planning in...

Modality
Radiotherapy Planning Imaging
Anatomy
Brain metastases in adults
Decision
2025-05-28
FDA-cleared K242748

Oncospace

Oncospace, Inc.

Oncospace supports trained radiation therapy professionals with protocol configuration, machine-learning achievable-dose prediction, planning-objective exchange, and plan review...

Modality
Radiotherapy Planning Imaging
Anatomy
Multi-region
Decision
2025-04-11
FDA-cleared K242925

MR Contour DL

GE HealthCare

MR Contour DL generates DICOM RT Structure Sets with initial organ-at-risk contours from adult MR images to accelerate radiation-treatment planning; users must verify, correct,...

Modality
Radiotherapy Planning Imaging
Anatomy
Adult anatomy represented by organs at risk on MR images
Decision
2025-04-01
FDA-cleared K242745

AI-Rad Companion Organs RT

Siemens Healthcare GmbH

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...

Modality
Radiotherapy Planning Imaging
Anatomy
Multi-region
Decision
2025-03-27
FDA-cleared K242822

ART-Plan+ (v.3.0.0)

Therapanacea SAS

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...

Modality
Radiotherapy Planning Imaging
Anatomy
Multi-region
Decision
2025-02-25
FDA-cleared K242994

OncoStudio (OS-01)

OncoSoft. Co., Ltd.

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...

Modality
Radiotherapy Planning Imaging
Anatomy
Multi-region
Decision
2025-02-24
FDA-cleared K250035

Contour ProtégéAI+

MIM Software Inc.

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
Decision
2025-02-03
FDA-cleared K243538

uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S)

Shanghai United Imaging Healthcare Co.,Ltd.

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
Decision
2024-12-12
FDA-cleared K242729

AutoContour (Model RADAC V4)

Radformation, Inc.

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...

Modality
Radiotherapy Planning Imaging
Anatomy
Multi-region
Decision
2024-12-09
FDA-cleared K241490

Contour+ (MVision AI Segmentation)

MVision AI Oy

Contour+ generates initial CT and MR anatomical contours across head and neck, brain, breast, thoracoabdominal, and pelvic radiation-treatment planning workflows for qualified...

Modality
Radiotherapy Planning Imaging
Anatomy
Multi-region
Decision
2024-10-18
FDA-cleared K241837

Limbus Contour

Limbus AI Inc.

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...

Modality
Radiotherapy Planning Imaging
Anatomy
Multi-region
Decision
2024-10-09
FDA-cleared K242300

MI View&GO

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...

Modality
Radiological images; modality varies or is not specified in FDA list
Anatomy
Multi-region PET, nuclear-medicine, CT, and MR studies
Decision
2024-08-30
FDA-cleared K241596

uMI Panvivo

Shanghai United Imaging Healthcare Co., Ltd.

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
Decision
2024-08-15
FDA-cleared K232799

syngo.via RT Image Suite

Siemens Medical Solutions USA, Inc.

syngo.via RT Image Suite VB80 supports trained radiation-oncology professionals with multimodality visualization, registration, advanced contouring, treatment preparation,...

Modality
Radiotherapy Planning Imaging
Anatomy
Multi-region
Decision
2024-04-26
FDA-cleared K234068

ART-Plan (v.2.2.0)

Therapanacea SAS

ART-Plan v2.2.0 assists trained radiation therapy professionals with multimodality contouring and registration, automatic treatment planning, synthetic CT, dose computation, and...

Modality
Radiotherapy Planning Imaging
Anatomy
Multi-region
Decision
2024-04-22
FDA-cleared K232899

AI-Rad Companion Organs RT

Siemens Medical Solutions U.S.A.

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...

Modality
Radiotherapy Planning Imaging
Anatomy
Multi-region
Decision
2024-04-03
FDA-cleared K231855

QOCA® image Smart RT Contouring System

Quanta Computer Inc.

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
Decision
2024-02-13
FDA-cleared K233677

Biograph VK10

Siemens Medical Solutions USA, Inc.

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
Decision
2024-01-12
FDA-cleared K232479

ART-Plan

TheraPanacea

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...

Modality
Radiotherapy Planning Imaging
Anatomy
Multi-region
Decision
2023-12-22
FDA-cleared K231765

Contour ProtégéAI

MIM Software Inc.

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
Decision
2023-11-08
FDA-cleared K231928

EFAI RTSUITE CT HCAP-Segmentation System

Ever Fortune.AI Co., Ltd.

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
Decision
2023-09-25
FDA-cleared K231833

Biograph Vision.X and Biograph Vision.X Edge

Siemens Medical Solutions USA, Inc.

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
Decision
2023-07-13
FDA-cleared K223724

MOZI TPS

Manteia Technologies Co., Ltd.

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
Decision
2023-07-10
FDA-cleared K222728

Radiation Planning Assistant (RPA)

University of Texas, MD Anderson Cancer Center

Radiation Planning Assistant creates initial CT-based contours and photon external-beam treatment plans for head-and-neck, cervical, breast, and whole-brain radiotherapy; every...

Modality
Radiotherapy Planning Imaging
Anatomy
Multi-region
Decision
2023-05-17
FDA-cleared K230082

Auto Segmentation

GE Medical Systems, LLC

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...

Modality
Radiotherapy Planning Imaging
Anatomy
Multi-region
Decision
2023-05-04
FDA-cleared K230023

ART-Plan

Therapanacea SAS

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...

Modality
Radiotherapy Planning Imaging
Anatomy
Multi-region
Decision
2023-04-19
FDA-cleared K230685

AutoContour Model RADAC V3

Radformation, Inc.

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;...

Modality
Radiotherapy Planning Imaging
Anatomy
Multi-region
Decision
2023-04-14
FDA-cleared K230575

Limbus Contour

Limbus AI Inc.

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...

Modality
Radiotherapy Planning Imaging
Anatomy
Multi-region
Decision
2023-04-07
FDA-cleared K223774

Contour ProtégéAI

MIM Software Inc.

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
Decision
2023-04-06
FDA-cleared K221706

AccuContour

Manteia Technologies Co., Ltd.

AccuContour generates and supports editing of organ-at-risk contours from multimodality imaging, including noncontrast CT, for radiation-treatment planning, evaluation, and...

Modality
Radiotherapy Planning Imaging
Anatomy
Multi-region
Decision
2023-03-09
FDA-cleared K222803

Oncospace

Oncospace, Inc.

Oncospace supports trained radiation therapy professionals with protocol configuration, machine-learning achievable-dose prediction, planning-objective exchange, and plan review...

Modality
Radiotherapy Planning Imaging
Anatomy
Multi-region
Decision
2023-02-02
FDA-cleared K220408

AVIEW RT ACS

Coreline Soft Co.,Ltd

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
Decision
2022-11-10
FDA-cleared K221305

AI-Rad Companion Organs RT

Siemens Medical Solutions USA, Inc

AI-Rad Companion Organs RT VA40 automatically contours predefined structures from adult DICOM CT for qualified review and DICOM RTSTRUCT transfer; this release added 29...

Modality
Radiotherapy Planning Imaging
Anatomy
Multi-region
Decision
2022-10-14
FDA-cleared K220783

syngo.via RT Image Suite

Siemens Medical Solutions USA Inc.

syngo.via RT Image Suite VB70 supports multimodality radiation-therapy image review, registration, contouring, treatment preparation, DICOM export, and lobe-based lung ventilation...

Modality
Radiotherapy Planning Imaging
Anatomy
Multi-region
Decision
2022-09-07
FDA-cleared K211841

MRI Planner

Spectronic Medical AB

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...

Modality
Radiotherapy Planning Imaging
Anatomy
Brain
Decision
2022-08-25
FDA-cleared K220598

AutoContour Model RADAC V2

Radformation, Inc.

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;...

Modality
Radiotherapy Planning Imaging
Anatomy
Multi-region
Decision
2022-08-24
FDA-cleared K222172

MI View&GO

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...

Modality
Radiological images; modality varies or is not specified in FDA list
Anatomy
Whole body, organs, tumors, heart, brain, and oncology regions
Decision
2022-08-19
FDA-cleared K220813

ART-PLAN

TheraPanacea

ART-Plan v1.10.0 assists trained radiation therapy professionals with multimodality DICOM review and registration, CT and MR contouring, and supported MR pseudo-CT generation,...

Modality
Radiotherapy Planning Imaging
Anatomy
Multi-region
Decision
2022-06-17
FDA-cleared K212915

MVision AI Segmentation

MVision AI

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
Decision
2022-05-03
FDA-cleared K220141

RayStation 11B

RaySearch Laboratories AB (publ)

RayStation 11B is configurable radiation-treatment planning and analysis software for qualified staff, supporting image handling, contouring, multimodality fusion, dose...

Modality
Radiotherapy Planning Imaging
Anatomy
Multi-region
Decision
2022-04-15
FDA-cleared K212274

INT Contour

Carina Medical LLC

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...

Modality
Radiotherapy Planning Imaging
Anatomy
Head and neck, thorax, abdomen, and male pelvis
Decision
2022-04-08
FDA-cleared K214081

MRCAT Head & Neck

Philips Oy

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.

Modality
Radiotherapy Planning Imaging
Anatomy
Head/Neck
Decision
2022-04-05
FDA-cleared K213976

Contour ProtégéAI

MIM Software Inc.

Contour ProtégéAI creates machine-learning contours from CT and MR DICOM images to support quantitative analysis, adaptive therapy, radiotherapy planning, archiving, and...

Modality
Radiotherapy Planning Imaging
Anatomy
Normal structures in labeled CT locations; prostate, seminal vesicles, and urethra on T2 MR
Decision
2022-02-03
FDA-cleared K213155

RT-Mind-AI

MedMind Technology Co., Ltd.

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
Decision
2021-12-15
FDA-cleared K212218

Advanced Algorithms for Treatment Management Applications (AATMA)

Elekta Solutions AB

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
Decision
2021-10-25
FDA-cleared K210632

Contour ProtegeAI

MIM Software Inc.

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
Decision
2021-10-20
FDA-cleared K212116

VBrain-OAR

Vysioneer Inc.

VBrain-OAR provides the cleared image-processing and organ-at-risk contouring support described in K212116 for brain radiotherapy planning, with all contours requiring...

Modality
Radiotherapy Planning Imaging
Anatomy
Brain and intracranial organs at risk
Decision
2021-10-12
FDA-cleared K211867

RayStation 11.0

RaySearch Laboratories AB (publ)

RayStation 11.0 is configurable radiation-treatment planning and analysis software for qualified staff, supporting image handling, contouring, multimodality fusion, dose...

Modality
Radiotherapy Planning Imaging
Anatomy
Multi-region
Decision
2021-09-08
FDA-cleared K211881

AI Segmentation

Varian Medical Systems, Inc.

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...

Modality
Radiotherapy Planning Imaging
Anatomy
Multi-region
Decision
2021-09-02
FDA-cleared K211764

Vereos PET/CT

Philips Medical Systems Nederland B.V.

Vereos PET/CT detects, localizes, diagnoses, stages, restages, and follows treatment response in oncology, cardiology, and neurology and can provide diagnostic CT and...

Modality
PET/SPECT/Nuclear Medicine
Anatomy
Multi-region
Decision
2021-08-06
FDA-cleared K211379

syngo.via RT Image Suite

Siemens Medical Solutions USA Inc.

syngo.via RT Image Suite VB60 supports trained radiation-oncology professionals with multimodality visualization, registration, contouring, treatment preparation, DICOM export,...

Modality
Radiotherapy Planning Imaging
Anatomy
Multi-region
Decision
2021-07-30
FDA-cleared K210645

RayStation 10.1

RaySearch Laboratories AB (publ)

RayStation 10.1 is configurable radiation-treatment planning software for radiation therapy and medical oncology that supports treatment-plan proposal, review, approval, and...

Modality
Radiotherapy Planning Imaging
Anatomy
Multi-region
Decision
2021-06-29
FDA-cleared K203610

Automatic Anatomy Recognition (AAR)

Quantitative Radiology Solutions, LLC

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...

Modality
Radiotherapy Planning Imaging
Anatomy
Head/Neck/Chest
Decision
2021-04-20
FDA-cleared K203469

AI Segmentation

Varian Medical Systems, Inc.

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...

Modality
Radiotherapy Planning Imaging
Anatomy
Multi-region
Decision
2021-04-19
FDA-cleared K202928

DV. Target

Deepvoxel INC

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
Decision
2021-04-02
FDA-cleared K203235

VBrain

Vysioneer Inc.

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...

Modality
Radiotherapy Planning Imaging
Anatomy
Brain tumors represented on contrast-enhanced MRI
Decision
2021-03-19
FDA-cleared K202284

Oncospace

Oncospace, Inc.

Oncospace supports trained radiation therapy professionals with protocol configuration, achievable-dose prediction, planning-objective exchange, and plan review for prostate,...

Modality
Radiotherapy Planning Imaging
Anatomy
Multi-region
Decision
2021-03-12
FDA-cleared K202700

ART-Plan

TheraPanacea

ART-Plan assists trained radiation therapy professionals with DICOM CT, MR, and PET image visualization, rigid and deformable registration, and automatic or assisted contouring...

Modality
Radiotherapy Planning Imaging
Anatomy
Multi-region
Decision
2021-01-14
FDA-cleared K201195

syngo.via MI Workflows, syngo MBF

Siemens Medical Solutions USA, Inc.

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
Decision
2020-11-18
FDA-cleared K193562

AI-Rad Companion Organs RT

Siemens Medical Solutions USA, Inc.

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...

Modality
Radiotherapy Planning Imaging
Anatomy
Multi-region
Decision
2020-11-06
FDA-cleared K200323

AutoContour

Radformation, Inc.

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...

Modality
Radiotherapy Planning Imaging
Anatomy
Multi-region
Decision
2020-10-30
FDA-cleared K200569

RayStation

RaySearch Laboratories AB (publ)

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...

Modality
Radiotherapy Planning Imaging
Anatomy
Multi-region
Decision
2020-09-24
FDA-cleared K201232

Limbus Contour

Limbus AI Inc.

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...

Modality
Radiotherapy Planning Imaging
Anatomy
Multi-region
Decision
2020-08-13
FDA-cleared K201444

Syngo.via RT Image Suite

Siemens Medical Solutions USA, Inc.

syngo.via RT Image Suite VB50 supports trained radiation-oncology professionals with multimodality visualization, registration, contouring, simple treatment preparation, and DICOM...

Modality
Radiotherapy Planning Imaging
Anatomy
Multi-region
Decision
2020-08-13
FDA-cleared K193252

Contour ProtegeAI

MIM Software Inc.

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
Decision
2020-07-02
FDA-cleared K191928

AccuContour

Xiamen Manteia Technology LTD.

AccuContour generates initial organ-at-risk contours from supported multimodality images for physician review in radiation-treatment planning and evaluation workflows.

Modality
Radiotherapy Planning Imaging
Anatomy
Multi-region
Decision
2020-02-28
FDA-cleared K192377

Ethos Treatment Management, Ethos Treatment Planning, Ethos Radiotherapy System, Halcyon

Varian Medical Systems, Inc.

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
Decision
2020-02-10
FDA-cleared K193109

MRCAT brain

Philips Medical Systems MR Finland

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.

Modality
Radiotherapy Planning Imaging
Anatomy
Brain
Decision
2020-01-24
FDA-cleared K192065

Syngo.Via RT Image Suite

Siemens Medical Solutions USA, Inc.

syngo.via RT Image Suite VB40 supports trained radiation-oncology professionals with multimodality visualization, registration, contouring, simple treatment preparation, DICOM...

Modality
Radiotherapy Planning Imaging
Anatomy
Multi-region
Decision
2019-09-18
FDA-cleared K190387

RayStation

RaySearch Laboratories AB (publ)

RayStation 8.1, marketed as RayStation 8B, is configurable radiation therapy treatment-planning and analysis software for trained, clinically qualified radiation therapy staff. It...

Modality
Radiotherapy Planning Imaging
Anatomy
Multi-region
Decision
2019-06-19
FDA-cleared K181572

Workflow Box

Mirada Medical Ltd.

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
Decision
2018-07-10
FDA-cleared K173420

Radiomics App v1.0

Microsoft Corp.

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
Decision
2017-12-27