Cleared Special

MODIFICATION TO: REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM WITH IMAGE PASTING AND AUTOPOSITIONING

K050704 · General Electric Co. · Radiology

Apr 2005

Decision

21d

Days

Class 2

Risk

About This 510(k) Submission

K050704 is an FDA 510(k) clearance for the MODIFICATION TO: REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM WITH IMAGE PASTING AND AUTOPOSITIONING, a System, X-ray, Stationary (Class II — Special Controls, product code KPR), submitted by General Electric Co. (Milwaukee, US). The FDA issued a Cleared decision on April 8, 2005, 21 days after receiving the submission on March 18, 2005. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1680.

Submission Details

510(k) Number	K050704 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 18, 2005
Decision Date	April 08, 2005
Days to Decision	21 days
Submission Type	Special
Review Panel	Radiology (RA)
Summary	Summary PDF