510(k) K222683

Fibroid Mapping Reviewer Application (FMRA) by Nesa Medtech Private Limited — Product Code LLZ

K222683 is an FDA 510(k) premarket notification submitted by Nesa Medtech Private Limited for the device "Fibroid Mapping Reviewer Application (FMRA)". The FDA issued a decision of Substantially Equivalent on July 17, 2023. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050.