510(k) K133914

VERISUITE 1.8, VERISUITE-PARTICLE 1.8, VERISUITE, VERISUITE-PARTICLE by Medcom GmbH — Product Code LHN

K133914 is an FDA 510(k) premarket notification submitted by Medcom GmbH for the device "VERISUITE 1.8, VERISUITE-PARTICLE 1.8, VERISUITE, VERISUITE-PARTICLE". The FDA issued a decision of Substantially Equivalent on April 3, 2014. The device falls under product code LHN (System, Radiation Therapy, Charged-Particle, Medical), a Class II device regulated under 21 CFR 892.5050. Medcom GmbH has at least 10 other 510(k) clearances on record.