510(k) K213351

ds Head 32ch 3.0T by Invivo Corporation (Business Trade Name: Philips) — Product Code MOS

K213351 is an FDA 510(k) premarket notification submitted by Invivo Corporation (Business Trade Name: Philips) for the device "ds Head 32ch 3.0T". The FDA issued a decision of Substantially Equivalent on October 29, 2021. 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.