QPN
- 产品代码
- QPN
- 器械名称
- Software Algorithm Device To Assist Users In Digital Pathology
- 管理类别
- 第 2 类（Class II）
- 21 CFR 条款
- 21 CFR 864.3750
- FDA 专业组
- Pathology
- 上市路径
- 需提交 510(k) 上市前通告
- 该代码近三年的 510(k)
- 2 件
FDA 分类定义
A software algorithm device to assist users in digital pathology is an in vitro diagnostic device intended to evaluate acquired scanned pathology whole slide images. The device uses software algorithms to provide information to the user about presence, location, and characteristics of areas of the image with clinical implications. Information from this device is intended to assist the user in determining a pathology diagnosis.
该代码近三年的 510(k)（1 件）
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 |
|---|---|---|---|
| K241232 | 2025-01-24 | Ibex Medical Analytics , Ltd. | Galen Second Read 摘要 |
FDA 官方分类页： QPN
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。