MYN
- 产品代码
- MYN
- 器械名称
- Analyzer, Medical Image
- 管理类别
- 第 2 类（Class II）
- 21 CFR 条款
- 21 CFR 892.2070
- FDA 专业组
- Radiology
- 上市路径
- 需提交 510(k) 上市前通告
- 该代码近三年的 510(k)
- 39 件
FDA 分类定义
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
该代码近三年的 510(k)（29 件）
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 |
|---|---|---|---|
| K261059 | 2026-08-06 | Overjet, Inc. | Overjet Multi-Image Caries and Charting Assist 摘要 |
| K260851 | 2026-07-15 | Better Diagnostics AI Corp. | Better Diagnostics Dental Assist (BDDA) Version 1.0 摘要 |
| K252953 | 2026-05-11 | Velmeni, Inc. | Velmeni for Dentists (V4D) Endo-Perio 摘要 |
| K251934 | 2026-01-16 | Qure.Ai Technologies | qXR-Detect 摘要 |
| K252934 | 2026-01-15 | DGNCT, LLC | Diagnocat 摘要 |
| K253009 | 2026-01-07 | Dentsply Sirona, Inc. | DS Core Detect 摘要 |
| K252086 | 2025-11-17 | Nobel Biocare C/O Medicim NV | DTX Studio Assist 摘要 |
| K250525 | 2025-11-14 | Pearl, Inc. | Second Opinion® Panoramic 摘要 |
| K250264 | 2025-11-07 | Bench7, Inc. | SugarBug (1.x) 摘要 |
| K251002 | 2025-09-19 | Videahealth, Inc. | Videa Dental AI 摘要 |
| K250753 | 2025-09-02 | Velmeni, Inc. | VELMENI for DENTISTS (V4D) 摘要 |
| K243234 | 2025-06-12 | Pearl, Inc. | Second Opinion® CS 摘要 |
| K242437 | 2025-05-14 | Cube Click, Inc. | Smile Dx® 摘要 |
| K243893 | 2025-05-05 | Pearl, Inc. | Second Opinion® Pediatric 摘要 |
| K243239 | 2025-04-24 | Exo, Inc. | Lung AI (LAI001) 摘要 |
| K242600 | 2025-04-11 | Pearl, Inc. | Second Opinion Periapical Radiolucency Contours 摘要 |
| K243831 | 2025-03-26 | AZmed | Rayvolve LN 摘要 |
| K241725 | 2025-03-11 | Better Diagnostics AI Corp. | Better Diagnostics Caries Assist (BDCA) Version 1.0 摘要 |
| K241620 | 2025-02-27 | Gleamer Sas | ChestView US 摘要 |
| K242522 | 2025-01-16 | Pearl, Inc. | Second Opinion CC 摘要 |
| K240003 | 2024-08-30 | Velmeni, Inc. | Velmeni for Dentists (V4D) 摘要 |
| K233738 | 2024-03-04 | Overjet, Inc. | Overjet Caries Assist-Pediatric 摘要 |
| K231805 | 2023-12-22 | Qure.Ai Technologies | qXR-LN 摘要 |
| K232384 | 2023-12-15 | Videahealth, Inc. | Videa Dental Assist 摘要 |
| K230144 | 2023-10-06 | Denti.Ai Technology, Inc. | Denti.AI Detect 摘要 |
| K231001 | 2023-10-05 | Deeptek Medical Imaging Pvt, Ltd. | DeepTek CXR Analyzer v1.0 摘要 |
| K230085 | 2023-10-03 | Imagen Technologies, Inc. | Lung-CAD 摘要 |
| K231678 | 2023-09-21 | Overjet, Inc. | Overjet Periapical Radiolucency Assist 摘要 |
| K223811 | 2023-09-13 | Imagen Technologies, Inc. | Lung-CAD 摘要 |
FDA 官方分类页： MYN
分类与上市路径以 FDA 现行公告为准。本页数据来自 openFDA（CC0 公有领域），不构成注册策略建议。