510(k) K220144

Breast BI Coil Set 0.55T; Breast BI 7 MR Coil Set 1.5T; Breast BI 7 MR Coil Set 3T by Noras Mri Products GmbH — Product Code MOS

K220144 is an FDA 510(k) premarket notification submitted by Noras Mri Products GmbH for the device "Breast BI Coil Set 0.55T; Breast BI 7 MR Coil Set 1.5T; Breast BI 7 MR Coil Set 3T". The FDA issued a decision of Substantially Equivalent on April 8, 2022. 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.