510(k) K223555

Brainomix 360 e-CTP by Brainomix Limited — Product Code LLZ

K223555 is an FDA 510(k) premarket notification submitted by Brainomix Limited for the device "Brainomix 360 e-CTP". The FDA issued a decision of Substantially Equivalent on June 1, 2023. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050. Brainomix Limited has at least 10 other 510(k) clearances on record.