510(k) K191740

DORO LUCENT® iXI and iMRI Headrest System by Pro Med Instruments GmbH — Product Code HBL

K191740 is an FDA 510(k) premarket notification submitted by Pro Med Instruments GmbH for the device "DORO LUCENT® iXI and iMRI Headrest System". The FDA issued a decision of Substantially Equivalent on February 21, 2020. The device falls under product code HBL (Holder, Head, Neurosurgical (Skull Clamp)), a Class II device regulated under 21 CFR 882.4460. Pro Med Instruments GmbH has at least 5 other 510(k) clearances on record.