FDA 510(k) Applications for Medical Device Product Code "MYN"
(Analyzer,Medical Image)

FDA 510(k) Number Applicant Device Name Decision Date
K231001 DeepTek Medical Imaging Pvt Ltd DeepTek CXR Analyzer v1.0 10/05/2023
K230144 Denti.AI Technology, Inc. Denti.AI Detect 10/06/2023
K213353 Imagen Technologies, Inc Aorta-CAD 09/20/2022
K210666 Imagen Technologies, Inc Chest-CAD 07/20/2021
K223811 Imagen Technologies, Inc Lung-CAD 09/13/2023
K230085 Imagen Technologies, Inc Lung-CAD 10/03/2023
K223133 Imidex Inc. VisiRad XR 08/03/2023
K221921 Nobel Biocare AB DTX Studio Clinic 3.0 03/28/2023
K220928 Overjet Inc. Overjet Calculus Assist 12/16/2022
K231678 Overjet, Inc Overjet Periapical Radiolucency Assist 09/21/2023
K212519 Overjet, Inc. Overjet Caries Assist 05/10/2022
K222746 Overjet, Inc. Overjet Caries Assist 03/27/2023
K210365 Pearl Inc. Second Opinion 03/04/2022
K201560 Samsung Electronics Co.,Ltd. Auto Lung Nodule Detection 08/31/2021
K213795 VideaHealth, Inc Videa Caries Assist 04/21/2022


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