510(k) K191539

1.5T Endorectal Coil, 3.0T Endorectal Coil, ER Coil Support by Rapid Biomedical GmbH — Product Code MOS

K191539 is an FDA 510(k) premarket notification submitted by Rapid Biomedical GmbH for the device "1.5T Endorectal Coil, 3.0T Endorectal Coil, ER Coil Support". The FDA issued a decision of Substantially Equivalent on Jan 31, 2020. 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.