Cleared Traditional

K052995 - ADVANTAGE WORKSTATION 4.3. (FDA 510(k) Clearance)

K052995 · Ge Healthcare · Radiology device

Nov 2005

Decision

14d

Days

Class 2

Risk

K052995 is an FDA 510(k) clearance for the ADVANTAGE WORKSTATION 4.3.. This device is classified as a System, Image Processing, Radiological (Class II - Special Controls, product code LLZ).

Submitted by Ge Healthcare (Waukesha, US). The FDA issued a Cleared decision on November 8, 2005, 14 days after receiving the submission on October 25, 2005.

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

Submission Details

510(k) Number	K052995 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	October 25, 2005
Decision Date	November 08, 2005
Days to Decision	14 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF