Cleared Traditional

K130884 - XELERIS 3.1 PROCESSING AND REVIEW WORKSTATION (FDA 510(k) Clearance)

K130884 · Ge Medical Systems F.I. Haifa · Radiology device

Apr 2013

Decision

14d

Days

Class 2

Risk

K130884 is an FDA 510(k) clearance for the XELERIS 3.1 PROCESSING AND REVIEW WORKSTATION. This device is classified as a System, Image Processing, Radiological (Class II - Special Controls, product code LLZ).

Submitted by Ge Medical Systems F.I. Haifa (Tirat Hacarmel, IL). The FDA issued a Cleared decision on April 12, 2013, 14 days after receiving the submission on March 29, 2013.

This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number	K130884 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	March 29, 2013
Decision Date	April 12, 2013
Days to Decision	14 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF