FDA-cleared K253270

Contour ProtégéAI+

Mim Software, Inc.

FDA product code QKB identifies this device class as Radiological Image Processing Software For Radiation Therapy. To provide semi-automatic or fully-automated radiological image...

Modality
Radiotherapy Planning Imaging
Anatomy
N/A
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 CT or MR images for radiation therapy treatment planning. It generates...

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

syngo.via RT Image Suite VC10

Varian Medical Systems, Inc.

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
N/A
Decision
2026-03-18
FDA-cleared K252002

Monaco RTP System (6.3)

Elekta Solutions AB

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
N/A
Decision
2026-02-19
FDA-cleared K251306

Seg Pro V3 (RT-300)

Ever Fortune.Ai, Co., Ltd.

FDA product code QKB identifies this device class as Radiological Image Processing Software For Radiation Therapy. To provide semi-automatic or fully-automated radiological image...

Modality
Radiotherapy Planning Imaging
Anatomy
N/A
Decision
2026-01-28
FDA-cleared K251351

AccuContour 4.0

Manteia Technologies Co., Ltd.

FDA product code QKB identifies this device class as Radiological Image Processing Software For Radiation Therapy. To provide semi-automatic or fully-automated radiological image...

Modality
Radiotherapy Planning Imaging
Anatomy
N/A
Decision
2026-01-23
FDA-cleared K253091

ART-Plan+ (v3.1.0)

Therapanacea Sas

ART-Plan+ v3.1.0 assists trained radiation therapy professionals with CT and MR contour generation, automatic prostate plans, and supported CBCT-based offline adaptive assessment...

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

ARTAssistant

Manteia Technologies Co., Ltd.

FDA product code QKB identifies this device class as Radiological Image Processing Software For Radiation Therapy. To provide semi-automatic or fully-automated radiological image...

Modality
Radiotherapy Planning Imaging
Anatomy
N/A
Decision
2025-12-05
FDA-cleared K250023

SMART PCFD

Disior Ltd

FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....

Modality
Radiotherapy Planning Imaging
Anatomy
N/A
Decision
2025-09-29
FDA-cleared K250064

Dose+ (1.0)

Mvision AI Oy

Dose+ 1.0 predicts a patient-specific three-dimensional dose distribution for men receiving external-beam radiotherapy for localized prostate cancer or prostate cancer with...

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

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
Neurovascular
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

FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....

Modality
Radiotherapy Planning Imaging
Anatomy
Vascular
Decision
2025-06-13
FDA-cleared K250427

TAIMedImg DeepMets

Taiwan Medical Imaging Co., Ltd.

FDA product code QKB identifies this device class as Radiological Image Processing Software For Radiation Therapy. To provide semi-automatic or fully-automated radiological image...

Modality
Radiotherapy Planning Imaging
Anatomy
N/A
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

FDA product code QKB identifies this device class as Radiological Image Processing Software For Radiation Therapy. To provide semi-automatic or fully-automated radiological image...

Modality
Radiotherapy Planning Imaging
Anatomy
N/A
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.

FDA product code QKB identifies this device class as Radiological Image Processing Software For Radiation Therapy. To provide semi-automatic or fully-automated radiological image...

Modality
Radiotherapy Planning Imaging
Anatomy
N/A
Decision
2025-02-03
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 K232928

DeepContour (V1.0)

Wisdom Technologies., Inc.

FDA product code QKB identifies this device class as Radiological Image Processing Software For Radiation Therapy. To provide semi-automatic or fully-automated radiological image...

Modality
Radiotherapy Planning Imaging
Anatomy
N/A
Decision
2024-05-07
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.

FDA product code QKB identifies this device class as Radiological Image Processing Software For Radiation Therapy. To provide semi-automatic or fully-automated radiological image...

Modality
Radiotherapy Planning Imaging
Anatomy
N/A
Decision
2024-02-13
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.

FDA product code QKB identifies this device class as Radiological Image Processing Software For Radiation Therapy. To provide semi-automatic or fully-automated radiological image...

Modality
Radiotherapy Planning Imaging
Anatomy
N/A
Decision
2023-11-08
FDA-cleared K231928

EFAI RTSUITE CT HCAP-Segmentation System

Ever Fortune.AI Co., Ltd.

FDA product code QKB identifies this device class as Radiological Image Processing Software For Radiation Therapy. To provide semi-automatic or fully-automated radiological image...

Modality
Radiotherapy Planning Imaging
Anatomy
N/A
Decision
2023-09-25
FDA-cleared K223724

MOZI TPS

Manteia Technologies Co., Ltd.

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
N/A
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.

FDA product code QKB identifies this device class as Radiological Image Processing Software For Radiation Therapy. To provide semi-automatic or fully-automated radiological image...

Modality
Radiotherapy Planning Imaging
Anatomy
N/A
Decision
2023-04-06
FDA-cleared K221706

AccuContour

Manteia Technologies Co., Ltd.

FDA product code QKB identifies this device class as Radiological Image Processing Software For Radiation Therapy. To provide semi-automatic or fully-automated radiological image...

Modality
Radiotherapy Planning Imaging
Anatomy
N/A
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

FDA product code QKB identifies this device class as Radiological Image Processing Software For Radiation Therapy. To provide semi-automatic or fully-automated radiological image...

Modality
Radiotherapy Planning Imaging
Anatomy
N/A
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

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
N/A
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 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

FDA product code QKB identifies this device class as Radiological Image Processing Software For Radiation Therapy. To provide semi-automatic or fully-automated radiological image...

Modality
Radiotherapy Planning Imaging
Anatomy
N/A
Decision
2022-05-03
FDA-cleared K220264

EFAI RTSuite CT HN-Segmentation System

Ever Fortune.AI Co., Ltd.

FDA product code QKB identifies this device class as Radiological Image Processing Software For Radiation Therapy. To provide semi-automatic or fully-automated radiological image...

Modality
Radiotherapy Planning Imaging
Anatomy
N/A
Decision
2022-04-28
FDA-cleared K220141

RayStation 11B

RaySearch Laboratories AB (publ)

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
N/A
Decision
2022-04-15
FDA-cleared K212274

INT Contour

Carina Medical LLC

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
N/A
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.

FDA product code QKB identifies this device class as Radiological Image Processing Software For Radiation Therapy. To provide semi-automatic or fully-automated radiological image...

Modality
Radiotherapy Planning Imaging
Anatomy
N/A
Decision
2022-02-03
FDA-cleared K213155

RT-Mind-AI

MedMind Technology Co., Ltd.

FDA product code QKB identifies this device class as Radiological Image Processing Software For Radiation Therapy. To provide semi-automatic or fully-automated radiological image...

Modality
Radiotherapy Planning Imaging
Anatomy
N/A
Decision
2021-12-15
FDA-cleared K210632

Contour ProtegeAI

MIM Software Inc.

FDA product code QKB identifies this device class as Radiological Image Processing Software For Radiation Therapy. To provide semi-automatic or fully-automated radiological image...

Modality
Radiotherapy Planning Imaging
Anatomy
N/A
Decision
2021-10-20
FDA-cleared K212116

VBrain-OAR

Vysioneer Inc.

FDA product code QKB identifies this device class as Radiological Image Processing Software For Radiation Therapy. To provide semi-automatic or fully-automated radiological image...

Modality
Radiotherapy Planning Imaging
Anatomy
Brain
Decision
2021-10-12
FDA-cleared K211867

RayStation 11.0

RaySearch Laboratories AB (publ)

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
N/A
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 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)

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
N/A
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

FDA product code QKB identifies this device class as Radiological Image Processing Software For Radiation Therapy. To provide semi-automatic or fully-automated radiological image...

Modality
Radiotherapy Planning Imaging
Anatomy
N/A
Decision
2021-04-02
FDA-cleared K203235

VBrain

Vysioneer Inc.

FDA product code QKB identifies this device class as Radiological Image Processing Software For Radiation Therapy. To provide semi-automatic or fully-automated radiological image...

Modality
Radiotherapy Planning Imaging
Anatomy
Brain
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 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.

FDA product code QKB identifies this device class as Radiological Image Processing Software For Radiation Therapy. To provide semi-automatic or fully-automated radiological image...

Modality
Radiotherapy Planning Imaging
Anatomy
N/A
Decision
2020-07-02
FDA-cleared K191928

AccuContour

Xiamen Manteia Technology LTD.

FDA product code QKB identifies this device class as Radiological Image Processing Software For Radiation Therapy. To provide semi-automatic or fully-automated radiological image...

Modality
Radiotherapy Planning Imaging
Anatomy
N/A
Decision
2020-02-28
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 K191384

RayCare 2.3

RaySearch Laboratories AB (publ)

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
N/A
Decision
2019-07-08
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.

FDA product code QKB identifies this device class as Radiological Image Processing Software For Radiation Therapy. To provide semi-automatic or fully-automated radiological image...

Modality
Radiotherapy Planning Imaging
Anatomy
N/A
Decision
2018-07-10