PCS
- 产品代码
- PCS
- 器械名称
- Liver Iron Concentration Imaging Companion Diagnostic For Deferasirox
- 管理类别
- 第 2 类（Class II）
- 21 CFR 条款
- 21 CFR 892.1001
- FDA 专业组
- Radiology
- 上市路径
- 需提交 510(k) 上市前通告
- 该代码近三年的 510(k)
- 3 件
FDA 分类定义
Intended for diagnostic use to present images that reflect the magnetic resonance spectra for the determination of iron in the liver for any indication where an assessment of liver iron concentration is needed. For non-transfusion-dependent thalassemia (NTDT) patients, is intended as an aid in the assessment of NTDT patients for whom deferasirox therapy is being considered and for monitoring of NTDT patients receiving deferasirox therapy.
FDA 官方分类页： PCS
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。