QFM
- 产品代码
- QFM
- 器械名称
- Radiological Computer-Assisted Prioritization Software For Lesions
- 管理类别
- 第 2 类（Class II）
- 21 CFR 条款
- 21 CFR 892.2080
- 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)
- 41 件
FDA 分类定义
Radiological computer-assisted prioritization software for lesions is an image processing device intended to aid in prioritization and triage of time sensitive patient detection and diagnosis based on the analysis of medical images acquired from radiological signal acquisition systems. The device identifies or prioritizes time sensitive imaging for review by prespecified clinical users based on software-based image analysis but does not provide information from the image analysis other than triage and notification.
该代码近三年的 510(k)（12 件）
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 |
|---|---|---|---|
| K253751 | 2026-07-08 | Neurocareai, Inc. (Dba Savelife.Ai) | CXRDetectAI 摘要 |
| K252954 | 2026-05-04 | Neurocareai, Inc. (Dba Savelife.Ai) | MammoSightAI 摘要 |
| K252482 | 2025-12-11 | Medcognetics, Inc. | CogNet AI-MT+ 摘要 |
| K250831 | 2025-04-23 | Annalise-Ai | Annalise Enterprise 摘要 |
| K243808 | 2025-03-21 | AZmed | Rayvolve PTX-PE 摘要 |
| K243548 | 2024-12-11 | Aidoc Medical , Ltd. | BriefCase-Triage 摘要 |
| K241439 | 2024-11-15 | Vuno, Inc. | VUNO Med-Chest X-ray Triage/VUNO Med-CXR Link Triage 摘要 |
| K240612 | 2024-05-31 | Avicenna.Ai | CINA-VCF 摘要 |
| K233108 | 2024-05-23 | Vinbigdata Joint Stock Company | VinDr-Mammo 摘要 |
| K232410 | 2024-05-10 | Milvue | SmartChest 摘要 |
| K231871 | 2024-01-17 | Envisionit Deepai, Ltd. | Radify Triage 摘要 |
| K223754 | 2023-11-09 | Bering, Ltd. | BraveCX 摘要 |
FDA 官方分类页： QFM
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。