510(k) K984245

NON-INVASIVE DYNAMIC REFERENCE FRAME (DRF) FOR OPTICAL TRACKING SYSTEM, MODEL OTS by Radionics, Inc. — Product Code HAW

K984245 is an FDA 510(k) premarket notification submitted by Radionics, Inc. for the device "NON-INVASIVE DYNAMIC REFERENCE FRAME (DRF) FOR OPTICAL TRACKING SYSTEM, MODEL OTS". The FDA issued a decision of Substantially Equivalent on December 18, 1998. The device falls under product code HAW (Neurological Stereotaxic Instrument), a Class II device regulated under 21 CFR 882.4560. Radionics, Inc. has at least 10 other 510(k) clearances on record.