510(k) K190887

Leksell Vantage Stereotactic System by Elekta Instrument AB — Product Code HAW

K190887 is an FDA 510(k) premarket notification submitted by Elekta Instrument AB for the device "Leksell Vantage Stereotactic System". The FDA issued a decision of Substantially Equivalent on August 1, 2019. The device falls under product code HAW (Neurological Stereotaxic Instrument), a Class II device regulated under 21 CFR 882.4560. Elekta Instrument AB has at least 10 other 510(k) clearances on record.