510(k) K121950

MICROTARGETING XL STAR DRIVE SYSTEM by FHC, Inc. — Product Code HAW

K121950 is an FDA 510(k) premarket notification submitted by FHC, Inc. for the device "MICROTARGETING XL STAR DRIVE SYSTEM". The FDA issued a decision of Substantially Equivalent on July 26, 2012. The device falls under product code HAW (Neurological Stereotaxic Instrument), a Class II device regulated under 21 CFR 882.4560. FHC, Inc. has at least 10 other 510(k) clearances on record.