510(k) K203677

ViewPoint 6 by GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC — Product Code LLZ

K203677 is an FDA 510(k) premarket notification submitted by GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC for the device "ViewPoint 6". The FDA issued a decision of Substantially Equivalent on Jan 15, 2021. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050. GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC has 82 other 510(k) clearances on record.