510(k) K093984

PICA WHOLE BODY MRI SYSTEM MODEL TMS-MRI-3500WB-01 by Time Medical Limited — Product Code LNH

K093984 is an FDA 510(k) premarket notification submitted by Time Medical Limited for the device "PICA WHOLE BODY MRI SYSTEM MODEL TMS-MRI-3500WB-01". The FDA issued a decision of Substantially Equivalent on Mar 24, 2010. The device falls under product code LNH (System, Nuclear Magnetic Resonance Imaging), a Class II device regulated under 21 CFR 892.1000. Time Medical Limited has 5 other 510(k) clearances on record.