说明与适用边界
此页按所列地区、版本归档。标签内容可能更新，具体产品请核对原始来源；本站关联表示阅读线索，不表示药品与器械可兼容或可替换。
监管定义 / Regulatory definition
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.
监管信息 / Regulatory information
FDA product code: SHY
Device class: 2
Regulation: 878.1840
Specialty: General, Plastic Surgery
Implant flag: N
Life sustaining/supporting flag: N
使用说明核对
该条目描述监管产品类别，不对应某个型号。实际操作须使用该厂家、型号和软件版本的说明书，核对预期用途、适应证、禁忌、校准、耗材兼容性、清洁灭菌、维护与报警处理。类别资料不能替代厂家使用说明。
来源、版本与许可
- 资料类型
- FDA 器械监管分类（非厂家操作说明书）
- 版本
- 2026-10-08
- 获取时间
- 2026-10-08
- 许可
- openFDA public data; retain original label attribution. See 查看来源 and dataset source notices. Public access does not imply approval or unrestricted rights to every submitted label.