FDA-cleared K181572
Workflow Box
Mirada Medical Ltd.
Image analysis/processing.
- Modality
- Radiotherapy planning imaging
- Anatomy
- N/A
- Decision
- 2018-07-10
Modality
Radiotherapy planning imaging radiology AI tools
93 source-backed listings mapped to this modality. Use each profile to verify FDA file number, workflow fit, integration, deployment, and unknown fields.
FDA-cleared K190387
RayStation
RaySearch Laboratories AB (publ)
Image analysis/processing.
- Modality
- Radiotherapy planning imaging
- Anatomy
- N/A
- Decision
- 2019-06-19
FDA-cleared K191384
RayCare 2.3
RaySearch Laboratories AB (publ)
Image analysis/processing.
- Modality
- Radiotherapy planning imaging
- Anatomy
- N/A
- Decision
- 2019-07-08
FDA-cleared K191585
iNtuition-Structural Heart Module
TeraRecon Inc.
Image analysis/processing for Heart using Radiotherapy planning imaging.
- Modality
- Radiotherapy planning imaging
- Anatomy
- Heart
- Decision
- 2019-07-12
FDA-cleared K192065
Syngo.Via RT Image Suite
Siemens Medical Solutions USA, Inc.
Image analysis/processing.
- Modality
- Radiotherapy planning imaging
- Anatomy
- N/A
- Decision
- 2019-09-18
FDA-cleared K193109
MRCAT brain
Philips Medical Systems MR Finland
Image analysis/processing for Brain using Radiotherapy planning imaging.
- Modality
- Radiotherapy planning imaging
- Anatomy
- Brain
- Decision
- 2020-01-24
FDA-cleared K192377
Ethos Treatment Management, Ethos Treatment Planning, Ethos Radiotherapy System, Halcyon
Varian Medical Systems, Inc.
Image analysis/processing.
- Modality
- Radiotherapy planning imaging
- Anatomy
- N/A
- Decision
- 2020-02-10
FDA-cleared K191928
AccuContour
Xiamen Manteia Technology LTD.
Image analysis/processing.
- Modality
- Radiotherapy planning imaging
- Anatomy
- N/A
- Decision
- 2020-02-28
FDA-cleared K193252
Contour ProtegeAI
MIM Software Inc.
Image analysis/processing.
- Modality
- Radiotherapy planning imaging
- Anatomy
- N/A
- Decision
- 2020-07-02
FDA-cleared K201232
Limbus Contour
Limbus AI Inc.
Image analysis/processing.
- Modality
- Radiotherapy planning imaging
- Anatomy
- N/A
- Decision
- 2020-08-13
FDA-cleared K201444
Syngo.via RT Image Suite
Siemens Medical Solutions USA, Inc.
Image analysis/processing.
- Modality
- Radiotherapy planning imaging
- Anatomy
- N/A
- Decision
- 2020-08-13
FDA-cleared K200569
RayStation
RaySearch Laboratories AB (publ)
Image analysis/processing.
- Modality
- Radiotherapy planning imaging
- Anatomy
- N/A
- Decision
- 2020-09-24
FDA-cleared K200323
AutoContour
Radformation, Inc.
Image analysis/processing.
- Modality
- Radiotherapy planning imaging
- Anatomy
- N/A
- Decision
- 2020-10-30
FDA-cleared K193562
AI-Rad Companion Organs RT
Siemens Medical Solutions USA, Inc.
Image analysis/processing.
- Modality
- Radiotherapy planning imaging
- Anatomy
- N/A
- Decision
- 2020-11-06
FDA-cleared K202700
ART-Plan
TheraPanacea
Image analysis/processing.
- Modality
- Radiotherapy planning imaging
- Anatomy
- N/A
- Decision
- 2021-01-14
FDA-cleared K202284
Oncospace
Oncospace, Inc.
Image analysis/processing.
- Modality
- Radiotherapy planning imaging
- Anatomy
- N/A
- Decision
- 2021-03-12
FDA-cleared K203235
VBrain
Vysioneer Inc.
Image analysis/processing.
- Modality
- Radiotherapy planning imaging
- Anatomy
- N/A
- Decision
- 2021-03-19
FDA-cleared K202928
DV. Target
Deepvoxel INC
Image analysis/processing.
- Modality
- Radiotherapy planning imaging
- Anatomy
- N/A
- Decision
- 2021-04-02
FDA-cleared K203469
AI Segmentation
Varian Medical Systems, Inc.
Image analysis/processing.
- Modality
- Radiotherapy planning imaging
- Anatomy
- N/A
- Decision
- 2021-04-19
FDA-cleared K203610
Automatic Anatomy Recognition (AAR)
Quantitative Radiology Solutions, LLC
Image analysis/processing.
- Modality
- Radiotherapy planning imaging
- Anatomy
- N/A
- Decision
- 2021-04-20
FDA-cleared K210645
RayStation 10.1
RaySearch Laboratories AB (publ)
Image analysis/processing.
- Modality
- Radiotherapy planning imaging
- Anatomy
- N/A
- Decision
- 2021-06-29
FDA-cleared K211379
syngo.via RT Image Suite
Siemens Medical Solutions USA Inc.
Image analysis/processing.
- Modality
- Radiotherapy planning imaging
- Anatomy
- N/A
- Decision
- 2021-07-30
FDA-cleared K211881
AI Segmentation
Varian Medical Systems, Inc.
Image analysis/processing.
- Modality
- Radiotherapy planning imaging
- Anatomy
- N/A
- Decision
- 2021-09-02
FDA-cleared K211867
RayStation 11.0
RaySearch Laboratories AB (publ)
Image analysis/processing.
- Modality
- Radiotherapy planning imaging
- Anatomy
- N/A
- Decision
- 2021-09-08
FDA-cleared K212116
VBrain-OAR
Vysioneer Inc.
Image analysis/processing.
- Modality
- Radiotherapy planning imaging
- Anatomy
- N/A
- Decision
- 2021-10-12
FDA-cleared K210632
Contour ProtegeAI
MIM Software Inc.
Image analysis/processing.
- Modality
- Radiotherapy planning imaging
- Anatomy
- N/A
- Decision
- 2021-10-20
FDA-cleared K212218
Advanced Algorithms for Treatment Management Applications (AATMA)
Elekta Solutions AB
Image analysis/processing.
- Modality
- Radiotherapy planning imaging
- Anatomy
- N/A
- Decision
- 2021-10-25
FDA-cleared K213155
RT-Mind-AI
MedMind Technology Co., Ltd.
Image analysis/processing.
- Modality
- Radiotherapy planning imaging
- Anatomy
- N/A
- Decision
- 2021-12-15
FDA-cleared K213628
VBrain
Vysioneer Inc.
Image analysis/processing.
- Modality
- Radiotherapy planning imaging
- Anatomy
- N/A
- Decision
- 2021-12-16
FDA-cleared K213976
Contour ProtégéAI
MIM Software Inc.
Image analysis/processing.
- Modality
- Radiotherapy planning imaging
- Anatomy
- N/A
- Decision
- 2022-02-03
FDA-cleared K214081
MRCAT Head & Neck
Philips Oy
Image analysis/processing for Head/Neck using Radiotherapy planning imaging.
- Modality
- Radiotherapy planning imaging
- Anatomy
- Head/Neck
- Decision
- 2022-04-05
FDA-cleared K212274
INT Contour
Carina Medical LLC
Image analysis/processing.
- Modality
- Radiotherapy planning imaging
- Anatomy
- N/A
- Decision
- 2022-04-08
FDA-cleared K220141
RayStation 11B
RaySearch Laboratories AB (publ)
Image analysis/processing.
- Modality
- Radiotherapy planning imaging
- Anatomy
- N/A
- Decision
- 2022-04-15
FDA-cleared K220264
EFAI RTSuite CT HN-Segmentation System
Ever Fortune.AI Co., Ltd.
Image analysis/processing.
- Modality
- Radiotherapy planning imaging
- Anatomy
- N/A
- Decision
- 2022-04-28
FDA-cleared K212915
MVision AI Segmentation
MVision AI
Image analysis/processing.
- Modality
- Radiotherapy planning imaging
- Anatomy
- N/A
- Decision
- 2022-05-03
FDA-cleared K220813
ART-PLAN
TheraPanacea
Image analysis/processing.
- Modality
- Radiotherapy planning imaging
- Anatomy
- N/A
- Decision
- 2022-06-17
FDA-cleared K220598
AutoContour Model RADAC V2
Radformation, Inc.
Image analysis/processing.
- Modality
- Radiotherapy planning imaging
- Anatomy
- N/A
- Decision
- 2022-08-24
FDA-cleared K211841
MRI Planner
Spectronic Medical AB
Image analysis/processing.
- Modality
- Radiotherapy planning imaging
- Anatomy
- N/A
- Decision
- 2022-08-25
FDA-cleared K220783
syngo.via RT Image Suite
Siemens Medical Solutions USA Inc.
Image analysis/processing.
- Modality
- Radiotherapy planning imaging
- Anatomy
- N/A
- Decision
- 2022-09-07
FDA-cleared K221305
AI-Rad Companion Organs RT
Siemens Medical Solutions USA, Inc
Image analysis/processing.
- Modality
- Radiotherapy planning imaging
- Anatomy
- N/A
- Decision
- 2022-10-14
FDA-cleared K220408
AVIEW RT ACS
Coreline Soft Co.,Ltd
Image analysis/processing.
- Modality
- Radiotherapy planning imaging
- Anatomy
- N/A
- Decision
- 2022-11-10
FDA-cleared K221868
QOCA image Smart CXR Image Processing System
Quanta Computer Inc.
Image analysis/processing for Chest/Lung using Radiotherapy planning imaging.
- Modality
- Radiotherapy planning imaging
- Anatomy
- Chest/Lung
- Decision
- 2023-01-27
FDA-cleared K222803
Oncospace
Oncospace, Inc.
Image analysis/processing.
- Modality
- Radiotherapy planning imaging
- Anatomy
- N/A
- Decision
- 2023-02-02
FDA-authorized DEN220063
Caption Interpretation Automated Ejection Fraction Software
Caption Health, Inc
Quantification/measurement
- Modality
- Radiotherapy planning imaging
- Anatomy
- N/A
- Decision
- 2023-02-24
FDA-cleared K221706
AccuContour
Manteia Technologies Co., Ltd.
Image analysis/processing.
- Modality
- Radiotherapy planning imaging
- Anatomy
- N/A
- Decision
- 2023-03-09
FDA-cleared K222312
RayStation 12A
RaySearch Laboratories AB (publ)
Image analysis/processing.
- Modality
- Radiotherapy planning imaging
- Anatomy
- N/A
- Decision
- 2023-03-29
FDA-cleared K223774
Contour ProtégéAI
MIM Software Inc.
Image analysis/processing.
- Modality
- Radiotherapy planning imaging
- Anatomy
- N/A
- Decision
- 2023-04-06
FDA-cleared K230575
Limbus Contour
Limbus AI Inc.
Image analysis/processing.
- Modality
- Radiotherapy planning imaging
- Anatomy
- N/A
- Decision
- 2023-04-07
FDA-cleared K230685
AutoContour Model RADAC V3
Radformation, Inc.
Image analysis/processing.
- Modality
- Radiotherapy planning imaging
- Anatomy
- N/A
- Decision
- 2023-04-14
FDA-cleared K230023
ART-Plan
Therapanacea SAS
Image analysis/processing.
- Modality
- Radiotherapy planning imaging
- Anatomy
- N/A
- Decision
- 2023-04-19
FDA-cleared K230082
Auto Segmentation
GE Medical Systems, LLC
Image analysis/processing.
- Modality
- Radiotherapy planning imaging
- Anatomy
- N/A
- Decision
- 2023-05-04
FDA-cleared K222728
Radiation Planning Assistant (RPA)
University of Texas, MD Anderson Cancer Center
Image analysis/processing.
- Modality
- Radiotherapy planning imaging
- Anatomy
- N/A
- Decision
- 2023-05-17
FDA-cleared K223724
MOZI TPS
Manteia Technologies Co., Ltd.
Image analysis/processing.
- Modality
- Radiotherapy planning imaging
- Anatomy
- N/A
- Decision
- 2023-07-10
FDA-cleared K223106
Brainlab Elements Image Fusion, Contouring (4.5);Image Fusion (4.5);Fibertracking (2.0);BOLD MRI Mapping (1.0);Image Fusion Angio (1.0)
Brainlab AG
Image analysis/processing for Vascular using Radiotherapy planning imaging.
- Modality
- Radiotherapy planning imaging
- Anatomy
- Vascular
- Decision
- 2023-07-14
FDA-cleared K231928
EFAI RTSUITE CT HCAP-Segmentation System
Ever Fortune.AI Co., Ltd.
Image analysis/processing.
- Modality
- Radiotherapy planning imaging
- Anatomy
- N/A
- Decision
- 2023-09-25
FDA-cleared K232023
Momentum Spine
Momentum Health Inc.
Image analysis/processing for Spine using Radiotherapy planning imaging.
- Modality
- Radiotherapy planning imaging
- Anatomy
- Spine
- Decision
- 2023-10-04
FDA-cleared K231765
Contour ProtégéAI
MIM Software Inc.
Image analysis/processing.
- Modality
- Radiotherapy planning imaging
- Anatomy
- N/A
- Decision
- 2023-11-08
FDA-cleared K232479
ART-Plan
TheraPanacea
Image analysis/processing.
- Modality
- Radiotherapy planning imaging
- Anatomy
- N/A
- Decision
- 2023-12-22
FDA-authorized DEN220040
Fibresolve
Imvaria, Inc
Computer-aided detection/diagnosis
- Modality
- Radiotherapy planning imaging
- Anatomy
- N/A
- Decision
- 2024-01-12
FDA-cleared K231855
QOCA® image Smart RT Contouring System
Quanta Computer Inc.
Image analysis/processing.
- Modality
- Radiotherapy planning imaging
- Anatomy
- N/A
- Decision
- 2024-02-13
FDA-cleared K231683
inHEART Models
inHEART, SAS
Image analysis/processing.
- Modality
- Radiotherapy planning imaging
- Anatomy
- N/A
- Decision
- 2024-02-29
FDA-cleared K232899
AI-Rad Companion Organs RT
Siemens Medical Solutions U.S.A.
Image analysis/processing.
- Modality
- Radiotherapy planning imaging
- Anatomy
- N/A
- Decision
- 2024-04-03
FDA-cleared K234068
ART-Plan (v.2.2.0)
Therapanacea SAS
Image analysis/processing.
- Modality
- Radiotherapy planning imaging
- Anatomy
- N/A
- Decision
- 2024-04-22
FDA-cleared K232799
syngo.via RT Image Suite
Siemens Medical Solutions USA, Inc.
Image analysis/processing.
- Modality
- Radiotherapy planning imaging
- Anatomy
- N/A
- Decision
- 2024-04-26
FDA-cleared K232923
Ethos Treatment Management (3.0); Ethos Treatment Planning (2.0)
Varian Medical Systems Inc.
Image analysis/processing.
- Modality
- Radiotherapy planning imaging
- Anatomy
- N/A
- Decision
- 2024-04-30
FDA-cleared K232928
DeepContour (V1.0)
Wisdom Technologies., Inc.
Image analysis/processing.
- Modality
- Radiotherapy planning imaging
- Anatomy
- N/A
- Decision
- 2024-05-07
FDA-cleared K240642
SMART Bun-Yo-Matic CT
Disior Ltd
Image analysis/processing.
- Modality
- Radiotherapy planning imaging
- Anatomy
- N/A
- Decision
- 2024-06-20
FDA-cleared K240736
SMART Bun-Yo-Matic X-Ray
Disior Ltd
Image analysis/processing.
- Modality
- Radiotherapy planning imaging
- Anatomy
- N/A
- Decision
- 2024-07-02
FDA-cleared K233822
i2Contour
MRIMath LLC
Image analysis/processing.
- Modality
- Radiotherapy planning imaging
- Anatomy
- N/A
- Decision
- 2024-08-08
FDA-cleared K241837
Limbus Contour
Limbus AI Inc.
Image analysis/processing.
- Modality
- Radiotherapy planning imaging
- Anatomy
- N/A
- Decision
- 2024-10-09
FDA-cleared K241490
Contour+ (MVision AI Segmentation)
MVision AI Oy
Image analysis/processing.
- Modality
- Radiotherapy planning imaging
- Anatomy
- N/A
- Decision
- 2024-10-18
FDA-cleared K242729
AutoContour (Model RADAC V4)
Radformation, Inc.
Image analysis/processing.
- Modality
- Radiotherapy planning imaging
- Anatomy
- N/A
- Decision
- 2024-12-09
FDA-cleared K242467
IQ-UIP
Imbio, Inc.
Image analysis/processing.
- Modality
- Radiotherapy planning imaging
- Anatomy
- N/A
- Decision
- 2024-12-19
FDA-cleared K241891
ScreenDx
Imvaria, Inc
Image analysis/processing.
- Modality
- Radiotherapy planning imaging
- Anatomy
- N/A
- Decision
- 2025-01-10
FDA-cleared K250035
Contour ProtégéAI+
MIM Software Inc.
Image analysis/processing.
- Modality
- Radiotherapy planning imaging
- Anatomy
- N/A
- Decision
- 2025-02-03
FDA-cleared K242994
OncoStudio (OS-01)
OncoSoft. Co., Ltd.
Image analysis/processing.
- Modality
- Radiotherapy planning imaging
- Anatomy
- N/A
- Decision
- 2025-02-24
FDA-cleared K242822
ART-Plan+ (v.3.0.0)
Therapanacea SAS
Image analysis/processing.
- Modality
- Radiotherapy planning imaging
- Anatomy
- N/A
- Decision
- 2025-02-25
FDA-cleared K242745
AI-Rad Companion Organs RT
Siemens Healthcare GmbH
Image analysis/processing.
- Modality
- Radiotherapy planning imaging
- Anatomy
- N/A
- Decision
- 2025-03-27
FDA-cleared K242925
MR Contour DL
GE HealthCare
Image analysis/processing.
- Modality
- Radiotherapy planning imaging
- Anatomy
- N/A
- Decision
- 2025-04-01
FDA-cleared K240398
RayStation 2023B, RayPlan 2023B, RayStation 2024A, RayPlan 2024A, RayStation 2024A SP3, RayPlan 2024A SP3
RaySearch Laboratories AB (PUBL)
Image analysis/processing.
- Modality
- Radiotherapy planning imaging
- Anatomy
- N/A
- Decision
- 2025-04-04
FDA-cleared K242600
Second Opinion Periapical Radiolucency Contours
Pearl Inc.
Image analysis/processing.
- Modality
- Radiotherapy planning imaging
- Anatomy
- N/A
- Decision
- 2025-04-11
FDA-cleared K242748
Oncospace
Oncospace, Inc.
Image analysis/processing.
- Modality
- Radiotherapy planning imaging
- Anatomy
- N/A
- Decision
- 2025-04-11
FDA-cleared K243684
BrightHeart View Classifier
BrightHeart
Image analysis/processing.
- Modality
- Radiotherapy planning imaging
- Anatomy
- N/A
- Decision
- 2025-05-07
FDA-cleared K250427
TAIMedImg DeepMets
Taiwan Medical Imaging Co., Ltd.
Image analysis/processing.
- Modality
- Radiotherapy planning imaging
- Anatomy
- N/A
- Decision
- 2025-05-28
FDA-cleared K251456
BrightHeart View Classifier
BrightHeart
Image analysis/processing.
- Modality
- Radiotherapy planning imaging
- Anatomy
- N/A
- Decision
- 2025-06-05
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
Image analysis/processing for Vascular using Radiotherapy planning imaging.
- Modality
- Radiotherapy planning imaging
- Anatomy
- Vascular
- Decision
- 2025-06-13
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
Image analysis/processing for Neurovascular using Radiotherapy planning imaging.
- Modality
- Radiotherapy planning imaging
- Anatomy
- Neurovascular
- Decision
- 2025-06-17
FDA-cleared K250064
Dose+ (1.0)
Mvision AI Oy
Image analysis/processing.
- Modality
- Radiotherapy planning imaging
- Anatomy
- N/A
- Decision
- 2025-09-04
FDA-cleared K252105
Ligence Heart
Ligence, UAB
Image analysis/processing for Heart using Radiotherapy planning imaging.
- Modality
- Radiotherapy planning imaging
- Anatomy
- Heart
- Decision
- 2025-09-26
FDA-cleared K250023
SMART PCFD
Disior Ltd
Image analysis/processing.
- Modality
- Radiotherapy planning imaging
- Anatomy
- N/A
- Decision
- 2025-09-29
FDA-cleared K252041
Fibresolve (with PCCP)
Imvaria, Inc.
Image analysis/processing.
- Modality
- Radiotherapy planning imaging
- Anatomy
- N/A
- Decision
- 2025-11-07
FDA-cleared K250780
ARTAssistant
Manteia Technologies Co., Ltd.
Image analysis/processing.
- Modality
- Radiotherapy planning imaging
- Anatomy
- N/A
- Decision
- 2025-12-05
FDA-cleared K253091
ART-Plan+ (v3.1.0)
Therapanacea Sas
Image analysis/processing.
- Modality
- Radiotherapy planning imaging
- Anatomy
- N/A
- Decision
- 2025-12-23