NVV
- 产品代码
- NVV
- 器械名称
- Digital Image, Storage And Communications, Non-Diagnostic, Laboratory Information System
- 管理类别
- 第 1 类（Class I）
- 21 CFR 条款
- 21 CFR 862.2100
- FDA 专业组
- Clinical Chemistry
- 上市路径
- 豁免 510(k)（仍须遵守通用控制与注册列名）
FDA 分类定义
Intended for clinical laboratory image storage and communications. A clinical laboratory image storage and communications device is a device that provides electronic storage and retrieval functions, and provides electronic transfer for non-diagnostic clinical laboratory images. Images are not intended for diagnostic purposes and not intended for radiological images.
FDA 官方分类页： NVV
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。