510(k) K180129

Imbio Segmentation Editing Tool software by Imbio, LLC — Product Code LLZ

K180129 is an FDA 510(k) premarket notification submitted by Imbio, LLC for the device "Imbio Segmentation Editing Tool software". The FDA issued a decision of Substantially Equivalent on Mar 16, 2018. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050. Imbio, LLC has at least 5 other 510(k) clearances on record.