OAY
- 产品代码
- OAY
- 器械名称
- Light Source System, Diagnostic Endoscopic
- 管理类别
- 第 3 类（Class III）
- FDA 专业组
- Unknown
- 上市路径
- 需 PMA 上市前批准
FDA 分类定义
A fluorescence system intended for use as an adjunct to white light cystoscopy when used in combination with a photosensitizer for the detection of bladder cancer. Patients with known or suspected bladder cancer and/or recurrence of bladder cancer, in patients undergoing diagnostic testing for bladder cancer by cystoscopy or positive urine cytology or who present with hematuria and/or a positive urine cytology test.
FDA 官方分类页： OAY
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。