SHY
- 产品代码
- SHY
- 器械名称
- Software-Aided Adjunctive Diagnostic Device For Use By Healthcare Providers In Skin Wound Assessment.
- 管理类别
- 第 2 类（Class II）
- 21 CFR 条款
- 21 CFR 878.1840
- FDA 专业组
- General, Plastic Surgery
- 上市路径
- 需提交 510(k) 上市前通告
- 该代码近三年的 510(k)
- 1 件
- 其中 Summary 已存档
- 0 份，可直接下载
- FDA 历史累计 510(k)
- 1 件（全部年份；本站只收录近三年的明细）
FDA 分类定义
A software-aided adjunctive diagnostic device for use by healthcare providers in skin wound assessment uses a software algorithm to analyze optical or other physical properties of a skin wound without direct wound contact and returns characterizing information that may include classification, severity, or healing potential of the skin wound. The device is intended for prescription use by healthcare providers to provide adjunctive information to be used in conjunction with clinical assessment. It is not for use as a standalone diagnostic device.
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 | 摘要 |
|---|---|---|---|---|
| DEN250028 | 2026-05-21 | Spectralmd, Inc. | DeepView AI® System | — |
FDA 官方分类页： SHY
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。