510(k) K991237

XPLAN-2 WITH HEAD AND NECK LOCALIZER, MODEL HNL by Radionics, Inc. — Product Code MUJ

K991237 is an FDA 510(k) premarket notification submitted by Radionics, Inc. for the device "XPLAN-2 WITH HEAD AND NECK LOCALIZER, MODEL HNL". The FDA issued a decision of Substantially Equivalent on August 30, 1999. The device falls under product code MUJ (System, Planning, Radiation Therapy Treatment), a Class II device regulated under 21 CFR 892.5050. Radionics, Inc. has at least 10 other 510(k) clearances on record.