510(k) K180123

Breast BI 7 MR Coil 1.5T Mammavention by Noras Mri Products GmbH — Product Code MOS

K180123 is an FDA 510(k) premarket notification submitted by Noras Mri Products GmbH for the device "Breast BI 7 MR Coil 1.5T Mammavention". The FDA issued a decision of Substantially Equivalent on February 16, 2018. The device falls under product code MOS (Coil, Magnetic Resonance, Specialty), a Class II device regulated under 21 CFR 892.1000. Noras Mri Products GmbH has at least 9 other 510(k) clearances on record.