510(k) 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 by Philips Medical Systems Nederland B.V. — Product Code MOS

K262330 is an FDA 510(k) premarket notification submitted by Philips Medical Systems Nederland B.V. for the device "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". The FDA issued a decision of Substantially Equivalent on July 30, 2026. The device falls under product code MOS (Coil, Magnetic Resonance, Specialty), a Class II device regulated under 21 CFR 892.1000. Philips Medical Systems Nederland B.V. has at least 10 other 510(k) clearances on record.