510(k) K162052

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

K162052 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 August 18, 2016. 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.