Cleared Traditional

Xeleris V Processing and Review Systems

K201103 · Ge Healthcare · Radiology

Sep 2020

Decision

154d

Days

Class 2

Risk

About This 510(k) Submission

K201103 is an FDA 510(k) clearance for the Xeleris V Processing and Review Systems, a System, Image Processing, Radiological (Class II — Special Controls, product code LLZ), submitted by Ge Healthcare (Tirat Hacarmel, IL). The FDA issued a Cleared decision on September 25, 2020, 154 days after receiving the submission on April 24, 2020. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number	K201103 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 24, 2020
Decision Date	September 25, 2020
Days to Decision	154 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF