FDA 510(k) Applications for Medical Device Product Code "QKB"

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


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