Analyzer, Medical Image
Regulation 892.2070
10510(k)s in 12 months (40 all time)
0recalls in 12 months (3 all time)
0recalls that name a 510(k)
Top companies in MYN
| Company | 510(k)s | Recalls |
|---|---|---|
| Overjet, Inc. | 6 | 0 |
| Pearl, Inc. | 6 | 0 |
| Imagen Technologies, Inc. | 4 | 0 |
| Velmeni, Inc. | 3 | 0 |
| Videahealth, Inc. | 3 | 0 |
| Better Diagnostics AI Corp. | 2 | 0 |
| Gleamer | 2 | 0 |
| Qure.Ai Technologies | 2 | 0 |
| Riverain Medical Group | 0 | 2 |
| AZmed | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 9, 2026 | K252486 | ChestView US (1.1) Gleamer, FR | MYN |
| Aug 6, 2026 | K261059 | Overjet Multi-Image Caries and Charting Assist Overjet, Inc. | MYN |
| Jul 15, 2026 | K260851 | Better Diagnostics Dental Assist (BDDA) Version 1.0 Better Diagnostics AI Corp. | MYN |
| May 11, 2026 | K252953 | Velmeni for Dentists (V4D) Endo-Perio Velmeni, Inc. | MYN |
| Jan 16, 2026 | K251934 | qXR-Detect Qure.Ai Technologies, IN | MYN |
| Jan 15, 2026 | K252934 | Diagnocat DGNCT, LLC | MYN |
| Jan 7, 2026 | K253009 | DS Core Detect Dentsply Sirona, Inc. | MYN |
| Nov 17, 2025 | K252086 | DTX Studio Assist Nobel Biocare C/O Medicim NV, BE | MYN |
| Nov 14, 2025 | K250525 | Second Opinion® Panoramic Pearl, Inc. | MYN |
| Nov 7, 2025 | K250264 | SugarBug (1.x) Bench7, Inc. | MYN |
| Sep 19, 2025 | K251002 | Videa Dental AI Videahealth, Inc. | MYN |
| Sep 2, 2025 | K250753 | VELMENI for DENTISTS (V4D) Velmeni, Inc. | MYN |
| Jun 12, 2025 | K243234 | Second Opinion® CS Pearl, Inc. | MYN |
| May 14, 2025 | K242437 | Smile Dx® Cube Click, Inc. | MYN |
| May 5, 2025 | K243893 | Second Opinion® Pediatric Pearl, Inc. | MYN |
| Apr 24, 2025 | K243239 | Lung AI (LAI001) Exo, Inc. | MYN |
| Apr 11, 2025 | K242600 | Second Opinion Periapical Radiolucency Contours Pearl, Inc. | MYN |
| Mar 26, 2025 | K243831 | Rayvolve LN AZmed, FR | MYN |
| Mar 11, 2025 | K241725 | Better Diagnostics Caries Assist (BDCA) Version 1.0 Better Diagnostics AI Corp. | MYN |
| Feb 27, 2025 | K241620 | ChestView US Gleamer Sas, FR | MYN |
| Jan 16, 2025 | K242522 | Second Opinion CC Pearl, Inc. | MYN |
| Aug 30, 2024 | K240003 | Velmeni for Dentists (V4D) Velmeni, Inc. | MYN |
| Mar 4, 2024 | K233738 | Overjet Caries Assist-Pediatric Overjet, Inc. | MYN |
| Dec 22, 2023 | K231805 | qXR-LN Qure.Ai Technologies, IN | MYN |
| Dec 15, 2023 | K232384 | Videa Dental Assist Videahealth, Inc. | MYN |
| Oct 6, 2023 | K230144 | Denti.AI Detect Denti.Ai Technology, Inc., CA | MYN |
| Oct 5, 2023 | K231001 | DeepTek CXR Analyzer v1.0 Deeptek Medical Imaging Pvt, Ltd., IN | MYN |
| Oct 3, 2023 | K230085 | Lung-CAD Imagen Technologies, Inc. | MYN |
| Sep 21, 2023 | K231678 | Overjet Periapical Radiolucency Assist Overjet, Inc. | MYN |
| Sep 13, 2023 | K223811 | Lung-CAD Imagen Technologies, Inc. | MYN |
| Aug 3, 2023 | K223133 | VisiRad XR Imidex, Inc. | MYN |
| Mar 28, 2023 | K221921 | DTX Studio Clinic 3.0 Nobel Biocare AB, SE | MYN |
| Mar 27, 2023 | K222746 | Overjet Caries Assist Overjet, Inc. | MYN |
| Dec 16, 2022 | K220928 | Overjet Calculus Assist Overjet, Inc. | MYN |
| Sep 20, 2022 | K213353 | Aorta-CAD Imagen Technologies, Inc. | MYN |
| May 10, 2022 | K212519 | Overjet Caries Assist Overjet, Inc. | MYN |
| Apr 21, 2022 | K213795 | Videa Caries Assist Videahealth, Inc. | MYN |
| Mar 4, 2022 | K210365 | Second Opinion Pearl, Inc. | MYN |
| Aug 31, 2021 | K201560 | Auto Lung Nodule Detection Samsung Electronics Co., Ltd., KR | MYN |
| Jul 20, 2021 | K210666 | Chest-CAD Imagen Technologies, Inc. | MYN |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.