Cleared Special

ViewPoint 6

K203677 · GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC · Radiology
Jan 2021
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K203677 is an FDA 510(k) clearance for the ViewPoint 6, a System, Image Processing, Radiological (Class II — Special Controls, product code LLZ), submitted by GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC (Wauwatosa, US). The FDA issued a Cleared decision on January 15, 2021, 29 days after receiving the submission on December 17, 2020. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K203677 FDA.gov
FDA Decision Cleared SESE
Date Received December 17, 2020
Decision Date January 15, 2021
Days to Decision 29 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code LLZ — System, Image Processing, Radiological
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.2050