510(k) K092471

MODEL SENTINELLA 102 by General Equipment For Medical Imaging, S.A. — Product Code IYX

K092471 is an FDA 510(k) premarket notification submitted by General Equipment For Medical Imaging, S.A. for the device "MODEL SENTINELLA 102". The FDA issued a decision of Substantially Equivalent on October 2, 2009. The device falls under product code IYX (Camera, Scintillation (Gamma)), a Class I device regulated under 21 CFR 892.1100. General Equipment For Medical Imaging, S.A. has at least 3 other 510(k) clearances on record.