510(k) K071399

DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM, MODEL DVS-I-11: DVS INSERTION TOOL, DVS-D-A: DVS DOSIMETER, DVS-R-100 by Sicel Technologies, Inc. — Product Code LHN

K071399 is an FDA 510(k) premarket notification submitted by Sicel Technologies, Inc. for the device "DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM, MODEL DVS-I-11: DVS INSERTION TOOL, DVS-D-A: DVS DOSIMETER, DVS-R-100". The FDA issued a decision of Substantially Equivalent on June 20, 2007. 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.