Cleared Traditional

Centricity Universal Viewer

K182419 · Ge Healthcare · Radiology
Dec 2018
Decision
100d
Days
Class 2
Risk

About This 510(k) Submission

K182419 is an FDA 510(k) clearance for the Centricity 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 December 14, 2018, 100 days after receiving the submission on September 5, 2018. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K182419 FDA.gov
FDA Decision Cleared SESE
Date Received September 05, 2018
Decision Date December 14, 2018
Days to Decision 100 days
Submission Type Traditional
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