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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