Analyzer, Medical Image
FDA product code MYN · Class II (moderate risk) · 21 CFR 892.2070 · Radiology
For information on the MYN device, please see: https://www.federalregister.gov/documents/2020/01/22/2020-00494/radiology-devices-reclassification-of-medical-image-analyzers
40510(k) clearances
11PMA approvals
1recalls
Manufacturers
- Pearl, Inc. 6
- Overjet, Inc. 6
- Imagen Technologies, Inc. 4
- Videahealth, Inc. 3
- Velmeni, Inc. 3
- Qure.Ai Technologies 2
- Gleamer 2
- Better Diagnostics AI Corp. 2
- Dgnct, LLC 1
- Dentsply Sirona 1
- Nobel Biocare C/O Medicim NV 1
- Bench7, Inc. 1
- Cube Click, Inc. 1
- Exo, Inc. 1
- AZmed 1
- Denti.Ai Technology, Inc. 1
- Deeptek Medical Imaging Pvt, Ltd. 1
- Imidex, Inc. 1
- Nobel Biocare AB 1
- Samsung Electronics Co., Ltd. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252486 | ChestView US (1.1)MYN · Traditional | Gleamer | 09/09/2026SE |
| K261059 | Overjet Multi-Image Caries and Charting AssistMYN · Traditional | Overjet, Inc. | 08/06/2026SE |
| K260851 | Better Diagnostics Dental Assist (BDDA) Version 1.0MYN · Traditional | Better Diagnostics AI Corp. | 07/15/2026SE |
| K252953 | Velmeni for Dentists (V4D) Endo-PerioMYN · Traditional | Velmeni, Inc. | 05/11/2026SE |
| K251934 | qXR-DetectMYN · Traditional | Qure.Ai Technologies | 01/16/2026SE |
| K252934 | DiagnocatMYN · Traditional | Dgnct, LLC | 01/15/2026SE |
| K253009 | DS Core DetectMYN · Traditional | Dentsply Sirona, Inc. | 01/07/2026SE |
| K252086 | DTX Studio AssistMYN · Traditional | Nobel Biocare C/O Medicim NV | 11/17/2025SE |
| K250525 | Second Opinion® PanoramicMYN · Traditional | Pearl, Inc. | 11/14/2025SE |
| K250264 | SugarBug (1.x)MYN · Traditional | Bench7, Inc. | 11/07/2025SE |
| K251002 | Videa Dental AIMYN · Traditional | Videahealth, Inc. | 09/19/2025SE |
| K250753 | VELMENI for DENTISTS (V4D)MYN · Traditional | Velmeni, Inc. | 09/02/2025SE |
| K243234 | Second Opinion® CSMYN · Traditional | Pearl, Inc. | 06/12/2025SE |
| K242437 | Smile Dx®MYN · Traditional | Cube Click, Inc. | 05/14/2025SE |
| K243893 | Second Opinion® PediatricMYN · Traditional | Pearl, Inc. | 05/05/2025SE |
| K243239 | Lung AI (LAI001)MYN · Traditional | Exo, Inc. | 04/24/2025SE |
| K242600 | Second Opinion Periapical Radiolucency ContoursMYN · Traditional | Pearl, Inc. | 04/11/2025SE |
| K243831 | Rayvolve LNMYN · Traditional | AZmed | 03/26/2025SE |
| K241725 | Better Diagnostics Caries Assist (BDCA) Version 1.0MYN · Traditional | Better Diagnostics AI Corp. | 03/11/2025SE |
| K241620 | ChestView USMYN · Traditional | Gleamer Sas | 02/27/2025SE |
| K242522 | Second Opinion CCMYN · Traditional | Pearl, Inc. | 01/16/2025SE |
| K240003 | Velmeni for Dentists (V4D)MYN · Traditional | Velmeni, Inc. | 08/30/2024SE |
| K233738 | Overjet Caries Assist-PediatricMYN · Traditional | Overjet, Inc. | 03/04/2024SE |
| K231805 | qXR-LNMYN · Traditional | Qure.Ai Technologies | 12/22/2023SE |
| K232384 | Videa Dental AssistMYN · Traditional | Videahealth, Inc. | 12/15/2023SE |
| K230144 | Denti.AI DetectMYN · Traditional | Denti.Ai Technology, Inc. | 10/06/2023SE |
| K231001 | DeepTek CXR Analyzer v1.0MYN · Traditional | Deeptek Medical Imaging Pvt, Ltd. | 10/05/2023SE |
| K230085 | Lung-CADMYN · Traditional | Imagen Technologies, Inc. | 10/03/2023SE |
| K231678 | Overjet Periapical Radiolucency AssistMYN · Traditional | Overjet, Inc. | 09/21/2023SE |
| K223811 | Lung-CADMYN · Traditional | Imagen Technologies, Inc. | 09/13/2023SE |
| K223133 | VisiRad XRMYN · Traditional | Imidex, Inc. | 08/03/2023SE |
| K221921 | DTX Studio Clinic 3.0MYN · Traditional | Nobel Biocare AB | 03/28/2023SE |
| K222746 | Overjet Caries AssistMYN · Traditional | Overjet, Inc. | 03/27/2023SE |
| K220928 | Overjet Calculus AssistMYN · Traditional | Overjet, Inc. | 12/16/2022SE |
| K213353 | Aorta-CADMYN · Traditional | Imagen Technologies, Inc. | 09/20/2022SE |
| K212519 | Overjet Caries AssistMYN · Traditional | Overjet, Inc. | 05/10/2022SE |
| K213795 | Videa Caries AssistMYN · Traditional | Videahealth, Inc. | 04/21/2022SE |
| K210365 | Second OpinionMYN · Traditional | Pearl, Inc. | 03/04/2022SE |
| K201560 | Auto Lung Nodule DetectionMYN · Traditional | Samsung Electronics Co., Ltd. | 08/31/2021SE |
| K210666 | Chest-CADMYN · Traditional | Imagen Technologies, Inc. | 07/20/2021SE |
PMA approvals
- P160009 PowerLook® Tomo Detection Software · Icad, Inc. · 03/24/2017
- P150043 Qvcad System · Qview Medical, Inc. · 11/09/2016
- P120004 Parascript Accudetect 6.1.0 · Parascript, LLC · 08/22/2013
- P100007 Breast Companion Software System · Almen Laboratories, Inc. · 02/10/2012
- P100005 M-Vu Algorithm Engine · Icad, Inc. · 01/23/2012
- P030007 Kodak Mammography Cad Engine · Carestream Health, Inc. · 11/23/2004
- P010034 Second Look (TM) · Icad, Inc. · 01/31/2002
- P010038 Second Look · Icad, Inc. · 01/15/2002
- P000041 Rapidscreen RS-2000 · Riverain Medical Group · 07/12/2001
- P980025 Logicon Caries Detector · Carestream Dental, LLC · 09/25/1998
- P970058 M1000 Imagechecker · Hologic, Inc. · 06/26/1998
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1537-2015 Class II | Logicon Caries Detector Product Usage: Analyze inter-proximal tooth surfaces for decay…GA Industries is recalling the Logicon Caries Detector, version 5.0, for Carestream Dental because it was… | GA Industries | 04/06/2015Terminated |