510(k) K061051

DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM, MODELS DVS-I-11, DVS INSERTION TOOL, DVS-D-A, DVS DOSIMETER by Sicel Technologies, Inc. — Product Code LHN

K061051 is an FDA 510(k) premarket notification submitted by Sicel Technologies, Inc. for the device "DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM, MODELS DVS-I-11, DVS INSERTION TOOL, DVS-D-A, DVS DOSIMETER". The FDA issued a decision of Substantially Equivalent on June 13, 2006. The device falls under product code LHN (System, Radiation Therapy, Charged-Particle, Medical), a Class II device regulated under 21 CFR 892.5050. Sicel Technologies, Inc. has at least 6 other 510(k) clearances on record.