K262330

dS Breast 7ch 1.5TdS Breast 7ch 3.0TdS Breast 16ch 1.5TdS Breast 16ch 3.0TdS Breast Coil 7ch 1.5TdS Sentinelle Breast 16ch 1.5TdS Sentinelle Breast 16ch 3.0T

510(k) 号: K262330
器械名称: dS Breast 7ch 1.5TdS Breast 7ch 3.0TdS Breast 16ch 1.5TdS Breast 16ch 3.0TdS Breast Coil 7ch 1.5TdS Sentinelle Breast 16ch 1.5TdS Sentinelle Breast 16ch 3.0T
申请人: Philips Medical Systems Nederland B.V. NL
产品代码: MOS — Coil, Magnetic Resonance, Specialty
批准日期: 2026-07-30
受理日期: 2026-07-09
决定: Substantially Equivalent
审查途径: Special
咨询委员会: Radiology

510(k) Summary（FDA 官方 PDF）： K262330.pdf

FDA 官方记录： K262330

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。