510(k) K230803

ADAS 3D by Adas3D Medical S.L. — Product Code LLZ

K230803 is an FDA 510(k) premarket notification submitted by Adas3D Medical S.L. for the device "ADAS 3D". The FDA issued a decision of Substantially Equivalent on May 23, 2023. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050. Adas3D Medical S.L. has at least 3 other 510(k) clearances on record.