Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
MYN — Predicate Candidate Screening
39 FDA 510(k) clearances under this product code; the 50 most recent screened below.
206 daysmedian FDA review time
304 days90th percentile
39clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261059 | Overjet Multi-Image Caries and Charting Assist | Overjet, Inc. | 2026-08-06 | 128 | 0 |
| K260851 | Better Diagnostics Dental Assist (BDDA) Version 1.0 | Better Diagnostics AI Corp. | 2026-07-15 | 121 | 0 |
| K252953 | Velmeni for Dentists (V4D) Endo-Perio | Velmeni, Inc. | 2026-05-11 | 237 | 0 |
| K251934 | qXR-Detect | Qure.Ai Technologies | 2026-01-16 | 206 | 0 |
| K252934 | Diagnocat | DGNCT, LLC | 2026-01-15 | 122 | 0 |
| K253009 | DS Core Detect | Dentsply Sirona, Inc. | 2026-01-07 | 110 | 0 |
| K252086 | DTX Studio Assist | Nobel Biocare C/O Medicim NV | 2025-11-17 | 138 | 0 |
| K250525 | Second Opinion® Panoramic | Pearl, Inc. | 2025-11-14 | 266 | 0 |
| K250264 | SugarBug (1.x) | Bench7, Inc. | 2025-11-07 | 282 | 0 |
| K251002 | Videa Dental AI | Videahealth, Inc. | 2025-09-19 | 171 | 0 |
| K250753 | VELMENI for DENTISTS (V4D) | Velmeni, Inc. | 2025-09-02 | 174 | 0 |
| K243234 | Second Opinion® CS | Pearl, Inc. | 2025-06-12 | 245 | 0 |
| K242437 | Smile Dx® | Cube Click, Inc. | 2025-05-14 | 271 | 0 |
| K243893 | Second Opinion® Pediatric | Pearl, Inc. | 2025-05-05 | 138 | 0 |
| K243239 | Lung AI (LAI001) | Exo, Inc. | 2025-04-24 | 196 | 0 |
| K242600 | Second Opinion Periapical Radiolucency Contours | Pearl, Inc. | 2025-04-11 | 224 | 0 |
| K243831 | Rayvolve LN | AZmed | 2025-03-26 | 103 | 0 |
| K241725 | Better Diagnostics Caries Assist (BDCA) Version 1.0 | Better Diagnostics AI Corp. | 2025-03-11 | 270 | 0 |
| K241620 | ChestView US | Gleamer Sas | 2025-02-27 | 267 | 0 |
| K242522 | Second Opinion CC | Pearl, Inc. | 2025-01-16 | 146 | 0 |
| K240003 | Velmeni for Dentists (V4D) | Velmeni, Inc. | 2024-08-30 | 241 | 0 |
| K233738 | Overjet Caries Assist-Pediatric | Overjet, Inc. | 2024-03-04 | 103 | 0 |
| K231805 | qXR-LN | Qure.Ai Technologies | 2023-12-22 | 185 | 0 |
| K232384 | Videa Dental Assist | Videahealth, Inc. | 2023-12-15 | 129 | 0 |
| K230144 | Denti.AI Detect | Denti.Ai Technology, Inc. | 2023-10-06 | 261 | 0 |
| K231001 | DeepTek CXR Analyzer v1.0 | Deeptek Medical Imaging Pvt, Ltd. | 2023-10-05 | 181 | 0 |
| K230085 | Lung-CAD | Imagen Technologies, Inc. | 2023-10-03 | 265 | 0 |
| K231678 | Overjet Periapical Radiolucency Assist | Overjet, Inc. | 2023-09-21 | 104 | 0 |
| K223811 | Lung-CAD | Imagen Technologies, Inc. | 2023-09-13 | 267 | 0 |
| K223133 | VisiRad XR | Imidex, Inc. | 2023-08-03 | 304 | 0 |
| K221921 | DTX Studio Clinic 3.0 | Nobel Biocare AB | 2023-03-28 | 270 | 0 |
| K222746 | Overjet Caries Assist | Overjet, Inc. | 2023-03-27 | 196 | 0 |
| K220928 | Overjet Calculus Assist | Overjet, Inc. | 2022-12-16 | 260 | 0 |
| K213353 | Aorta-CAD | Imagen Technologies, Inc. | 2022-09-20 | 347 | 0 |
| K212519 | Overjet Caries Assist | Overjet, Inc. | 2022-05-10 | 273 | 0 |
| K213795 | Videa Caries Assist | Videahealth, Inc. | 2022-04-21 | 136 | 0 |
| K210365 | Second Opinion | Pearl, Inc. | 2022-03-04 | 389 | 0 |
| K201560 | Auto Lung Nodule Detection | Samsung Electronics Co., Ltd. | 2021-08-31 | 447 | 0 |
| K210666 | Chest-CAD | Imagen Technologies, Inc. | 2021-07-20 | 137 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda