510(k) K222781

Augmento by Deeptek Medical Imaging Private Limited — Product Code LLZ

K222781 is an FDA 510(k) premarket notification submitted by Deeptek Medical Imaging Private Limited for the device "Augmento". The FDA issued a decision of Substantially Equivalent on Apr 11, 2023. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050.