K253648

Ingenia, Ingenia CX, Ingenia Elition S/X, Ingenia Ambition S/X, BlueSeal SE/XE/QE, MR 5300 and MR 7700 MR Systems including Upgrades

510(k) 号: K253648
器械名称: Ingenia, Ingenia CX, Ingenia Elition S/X, Ingenia Ambition S/X, BlueSeal SE/XE/QE, MR 5300 and MR 7700 MR Systems including Upgrades
申请人: Philips Medical Systems Nederland B.V. NL
产品代码: LNH — System, Nuclear Magnetic Resonance Imaging
批准日期: 2026-02-23
受理日期: 2025-11-20
决定: Substantially Equivalent
审查途径: Abbreviated
咨询委员会: Radiology

也可从 FDA 官方下载： K253648.pdf

FDA 官方记录： K253648

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。