510(k) K083255

16CH AI BREAST COILS 1.5 T AND 3 T by Rapid Biomedical GmbH — Product Code MOS

K083255 is an FDA 510(k) premarket notification submitted by Rapid Biomedical GmbH for the device "16CH AI BREAST COILS 1.5 T AND 3 T". The FDA issued a decision of Substantially Equivalent on Nov 21, 2008. The device falls under product code MOS (Coil, Magnetic Resonance, Specialty), a Class II device regulated under 21 CFR 892.1000. Rapid Biomedical GmbH has 6 other 510(k) clearances on record.