510(k) K254190

dS Base 1.5T; dS Base 3.0T; dS Head 1.5T; dS Head 3.0T; dS HeadNeck 1.5T; dS HeadNeck 3.0T by Philips Medical Systems Nederland B.V. — Product Code MOS

K254190 is an FDA 510(k) premarket notification submitted by Philips Medical Systems Nederland B.V. for the device "dS Base 1.5T; dS Base 3.0T; dS Head 1.5T; dS Head 3.0T; dS HeadNeck 1.5T; dS HeadNeck 3.0T". The FDA issued a decision of Substantially Equivalent on January 14, 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.