Cleared Special

XELERIS 2 PROCESSING AND REVIEW WORKSTATION

K051673 · GE Medical Systems · Radiology

Jul 2005

Decision

25d

Days

Class 2

Risk

About This 510(k) Submission

K051673 is an FDA 510(k) clearance for the XELERIS 2 PROCESSING AND REVIEW WORKSTATION, a System, Image Processing, Radiological (Class II — Special Controls, product code LLZ), submitted by GE Medical Systems (Waukesha, US). The FDA issued a Cleared decision on July 18, 2005, 25 days after receiving the submission on June 23, 2005. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number	K051673 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 23, 2005
Decision Date	July 18, 2005
Days to Decision	25 days
Submission Type	Special
Review Panel	Radiology (RA)
Summary	Summary PDF