43 devices · 33 companies · 1998 to 2026
Product code MYN: Analyzer, Medical Image
43 devices under product code MYN, 1998 to 2026, from 33 companies. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (39 of 43 here), the regulation, and MAUDE report counts by product code.
Analyzer, Medical Image. 21 CFR 892.2070, Class II. 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 MAUDE held 5 adverse-event reports against this product code as of 2026-10-29; reports are unverified and the code is shared by every device of this type.
Retrieved from FDA public records.
Companies with more than one device here
Every device, newest decision first
| Decision | Device | Company | Panel | FDA |
|---|---|---|---|---|
| Velmeni for DentistsK252953 · 510(k) | Velmeni, Inc. | Radiology | database entry | |
| qXR-DetectK251934 · 510(k) | Qure.Ai Technologies | Radiology | database entry | |
| DiagnocatK252934 · 510(k) | DGNCT, LLC | Radiology | database entry | |
| DS Core DetectK253009 · 510(k) | Dentsply Sirona, Inc. | Radiology | database entry | |
| DTX Studio AssistK252086 · 510(k) | Nobel Biocare C/O Medicim NV | Radiology | database entry | |
| Second Opinion PanoramicK250525 · 510(k) | Pearl, Inc. | Radiology | database entry | |
| SugarBugK250264 · 510(k) | Bench7, Inc. | Radiology | database entry | |
| Videa Dental AIK251002 · 510(k) | VideaHealth Inc. | Radiology | database entry | |
| VELMENI for DENTISTSK250753 · 510(k) | Velmeni Inc. | Radiology | database entry | |
| Second Opinion CSK243234 · 510(k) | Pearl Inc. | Radiology | database entry | |
| Smile DxK242437 · 510(k) | Cube Click, Inc. | Radiology | database entry | |
| Second Opinion PediatricK243893 · 510(k) | Pearl, Inc. | Radiology | database entry | |
| Lung AIK243239 · 510(k) | Exo Inc | Radiology | database entry | |
| Second Opinion Periapical Radiolucency ContoursK242600 · 510(k) | Pearl Inc. | Radiology | database entry | |
| Rayvolve LNK243831 · 510(k) | AZmed | Radiology | database entry | |
| Better Diagnostics Caries AssistK241725 · 510(k) | Better Diagnostics AI Corp | Radiology | database entry | |
| ChestView USK241620 · 510(k) | Gleamer SAS | Radiology | database entry | |
| Second Opinion CCK242522 · 510(k) | Pearl Inc. | Radiology | database entry | |
| Velmeni for DentistsK240003 · 510(k) | Velmeni Inc. | Radiology | database entry | |
| Overjet Caries Assist-PediatricK233738 · 510(k) | Overjet, Inc | Radiology | database entry | |
| qXR-LNK231805 · 510(k) | Qure.ai Technologies | Radiology | database entry | |
| Videa Dental AssistK232384 · 510(k) | VideaHealth, Inc. | Radiology | database entry | |
| Denti.AI DetectK230144 · 510(k) | Denti.AI Technology, Inc. | Radiology | database entry | |
| DeepTek CXR Analyzer v1.0K231001 · 510(k) | DeepTek Medical Imaging Pvt Ltd | Radiology | database entry | |
| Lung-CADK230085 · 510(k) | Imagen Technologies, Inc | Radiology | database entry | |
| Overjet Periapical Radiolucency AssistK231678 · 510(k) | Overjet, Inc | Radiology | database entry | |
| Lung-CADK223811 · 510(k) | Imagen Technologies, Inc | Radiology | database entry | |
| VisiRad XRK223133 · 510(k) | Imidex Inc. | Radiology | database entry | |
| DTX Studio Clinic 3.0K221921 · 510(k) | Nobel Biocare AB | Radiology | database entry | |
| Overjet Caries AssistK222746 · 510(k) | Overjet, Inc. | Radiology | database entry | |
| Overjet Calculus AssistK220928 · 510(k) | Overjet Inc. | Radiology | database entry | |
| Aorta-CADK213353 · 510(k) | Imagen Technologies, Inc | Radiology | database entry | |
| Overjet Caries AssistK212519 · 510(k) | Overjet, Inc. | Radiology | database entry | |
| Videa Caries AssistK213795 · 510(k) | VideaHealth, Inc | Radiology | database entry | |
| Second OpinionK210365 · 510(k) | Pearl Inc. | Radiology | database entry | |
| Auto Lung Nodule DetectionK201560 · 510(k) | Samsung Electronics Co.,Ltd. | Radiology | database entry | |
| Chest-CADK210666 · 510(k) | Imagen Technologies, Inc | Radiology | database entry | |
| PowerLook Tomo Detection SoftwareP160009 · PMA | iCAD Inc | Radiology | database entry | |
| QVCAD SystemP150043 · PMA | QView Medical, Inc. | Radiology | database entry | |
| SECOND LOOKP010034 · PMA | ICAD, INC. | Radiology | database entry | |
| RAPIDSCREEN RS-2000P000041 · PMA | RIVERAIN MEDICAL GROUP | Radiology | database entry | |
| LOGICON CARIES DETECTORP980025 · PMA | CARESTREAM DENTAL LLC | Radiology | database entry | |
| M1000 IMAGECHECKERP970058 · PMA | Hologic, Inc. | Radiology | database entry |
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