K251645

Self-Propelled CT Scan Base Kit, CGBA-035A; Alphenix, INFX-8000C/B, INFX-8000C/S, V9.6 with Calculated DAP

510(k) 号: K251645
器械名称: Self-Propelled CT Scan Base Kit, CGBA-035A; Alphenix, INFX-8000C/B, INFX-8000C/S, V9.6 with Calculated DAP
申请人: Canon Medical Systems Corporation JP
产品代码: JAK — System, X-Ray, Tomography, Computed
批准日期: 2025-09-26
受理日期: 2025-05-29
决定: Substantially Equivalent
审查途径: Traditional
咨询委员会: Radiology

也可从 FDA 官方下载： K251645.pdf

FDA 官方记录： K251645

数据来自 openFDA 510(k) 数据集（CC0 公有领域），以 FDA 现行记录为准。510(k) 许可不等于 FDA 认证或批准。