QZL
- 产品代码
- QZL
- 器械名称
- Post-Ablation Tissue Response Prediction Software
- 管理类别
- 第 2 类(Class II)
- 21 CFR 条款
- 21 CFR 892.2052
- 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)
- 2 件
- 其中 Summary 已存档
- 1 份,可直接下载
- FDA 历史累计 510(k)
- 2 件(全部年份;本站只收录近三年的明细)
FDA 分类定义
A Post-ablation tissue response prediction software is an image processing device intended to aid physicians with adjunctive information in their clinical assessment of the ablation zone following a tissue ablation procedure. This device uses information extracted from medical images along with other clinical data to predict the ablation zone post treatment.
该代码近三年的 510(k)(2 件)
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 | 摘要 |
|---|---|---|---|---|
| K243084 | 2024-12-27 | Techsomed Medical Technologies , Ltd. | BioTraceIO Precision (2.0) | |
| DEN230020 | 2023-12-22 | Techsomed Medical Technologies , Ltd. | BioTraceIO Lite | — |
FDA 官方分类页: QZL
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。