FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K220408 |
Coreline Soft Co.,Ltd |
AVIEW RT ACS |
11/10/2022 |
K202928 |
Deepvoxel INC |
DV. Target |
04/02/2021 |
K212218 |
Elekta Solutions AB |
Advanced Algorithms for Treatment Management Applications (AATMA) |
10/25/2021 |
K231928 |
Ever Fortune.AI Co., Ltd. |
EFAI RTSUITE CT HCAP-Segmentation System |
09/25/2023 |
K220264 |
Ever Fortune.AI Co., Ltd. |
EFAI RTSuite CT HN-Segmentation System |
04/28/2022 |
K230082 |
GE Medical Systems, LLC |
Auto Segmentation |
05/04/2023 |
K221706 |
Manteia Technologies Co., Ltd. |
AccuContour |
03/09/2023 |
K213155 |
MedMind Technology Co., Ltd. |
RT-Mind-AI |
12/15/2021 |
K193252 |
MIM Software Inc. |
Contour ProtegeAI |
07/02/2020 |
K210632 |
MIM Software Inc. |
Contour ProtegeAI |
10/20/2021 |
K223774 |
MIM Software Inc. |
Contour ProtΘgΘAI |
04/06/2023 |
K213976 |
MIM Software Inc. |
Contour ProtΘgΘAI |
02/03/2022 |
K181572 |
Mirada Medical Ltd. |
Workflow Box |
07/10/2018 |
K212915 |
MVision AI |
MVision AI Segmentation |
05/03/2022 |
K203610 |
Quantitative Radiology Solutions, LLC |
Automatic Anatomy Recognition (AAR) |
04/20/2021 |
K200323 |
Radformation, Inc. |
AutoContour |
10/30/2020 |
K220598 |
Radformation, Inc. |
AutoContour Model RADAC V2 |
08/24/2022 |
K230685 |
Radformation, Inc. |
AutoContour Model RADAC V3 |
04/14/2023 |
K221305 |
Siemens Medical Solutions USA, Inc |
AI-Rad Companion Organs RT |
10/14/2022 |
K193562 |
Siemens Medical Solutions USA, Inc. |
AI-Rad Companion Organs RT |
11/06/2020 |
K202700 |
TheraPanacea |
ART-Plan |
01/14/2021 |
K220813 |
TheraPanacea |
ART-PLAN |
06/17/2022 |
K230023 |
Therapanacea SAS |
ART-Plan |
04/19/2023 |
K203235 |
Vysioneer Inc. |
VBrain |
03/19/2021 |
K213628 |
Vysioneer Inc. |
VBrain |
12/16/2021 |
K212116 |
Vysioneer Inc. |
VBrain-OAR |
10/12/2021 |
K191928 |
Xiamen Manteia Technology LTD. |
AccuContour |
02/28/2020 |