510(k) K043147

ACHIEVA FAMILY by Philips Medical Systems North America Co. — Product Code LNH

K043147 is an FDA 510(k) premarket notification submitted by Philips Medical Systems North America Co. for the device "ACHIEVA FAMILY". The FDA issued a decision of Substantially Equivalent on February 15, 2005. The device falls under product code LNH (System, Nuclear Magnetic Resonance Imaging), a Class II device regulated under 21 CFR 892.1000. Philips Medical Systems North America Co. has at least 10 other 510(k) clearances on record.