510(k) K210109

visor2 system by Eemagine Medical Imaging Solutions GmbH — Product Code HAW

K210109 is an FDA 510(k) premarket notification submitted by Eemagine Medical Imaging Solutions GmbH for the device "visor2 system". The FDA issued a decision of Substantially Equivalent on April 8, 2022. The device falls under product code HAW (Neurological Stereotaxic Instrument), a Class II device regulated under 21 CFR 882.4560. Eemagine Medical Imaging Solutions GmbH has at least 7 other 510(k) clearances on record.