510(k) K213727

dS Sentinelle Breast 16ch 3.0T Coil by Invivo Corporation (Business Trade Name: Philips) — Product Code MOS

K213727 is an FDA 510(k) premarket notification submitted by Invivo Corporation (Business Trade Name: Philips) for the device "dS Sentinelle Breast 16ch 3.0T Coil". The FDA issued a decision of Substantially Equivalent on August 8, 2022. The device falls under product code MOS (Coil, Magnetic Resonance, Specialty), a Class II device regulated under 21 CFR 892.1000. Invivo Corporation (Business Trade Name: Philips) has at least 5 other 510(k) clearances on record.