510(k) K143156

Sentinella 102; Sentinella 102 Horus by General Equipment For Medical Imaging (Oncovision- — Product Code IYX

K143156 is an FDA 510(k) premarket notification submitted by General Equipment For Medical Imaging (Oncovision- for the device "Sentinella 102; Sentinella 102 Horus". The FDA issued a decision of Substantially Equivalent on November 18, 2014. 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 (Oncovision- has at least 2 other 510(k) clearances on record.