510(k) K233348

16 Breast Coil by Philips Medical System Nederlands B.V. — Product Code MOS

K233348 is an FDA 510(k) premarket notification submitted by Philips Medical System Nederlands B.V. for the device "16 Breast Coil". The FDA issued a decision of Substantially Equivalent on October 24, 2023. The device falls under product code MOS (Coil, Magnetic Resonance, Specialty), a Class II device regulated under 21 CFR 892.1000.