Cleared Special

Universal Viewer

K211312 · Ge Healthcare · Radiology
May 2021
Decision
21d
Days
Class 2
Risk

About This 510(k) Submission

K211312 is an FDA 510(k) clearance for the Universal Viewer, a System, Image Processing, Radiological (Class II — Special Controls, product code LLZ), submitted by Ge Healthcare (Chicago, US). The FDA issued a Cleared decision on May 21, 2021, 21 days after receiving the submission on April 30, 2021. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K211312 FDA.gov
FDA Decision Cleared SESE
Date Received April 30, 2021
Decision Date May 21, 2021
Days to Decision 21 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