Cleared Traditional

K042525 - CENTRICITY RADIOLOGY RA600/CENTRICITY CARDIOLOGY CA1000/CENTRICITY DIGITAL HARDCOPY WORKSTATION (FDA 510(k) Clearance)

K042525 · Ge Medical Systems Information Technologies · Radiology device

Oct 2004

Decision

14d

Days

Class 2

Risk

K042525 is an FDA 510(k) clearance for the CENTRICITY RADIOLOGY RA600/CENTRICITY CARDIOLOGY CA1000/CENTRICITY DIGITAL HARDCOPY WORKSTATION. This device is classified as a System, Image Processing, Radiological (Class II - Special Controls, product code LLZ).

Submitted by Ge Medical Systems Information Technologies (Mount Prospect, US). The FDA issued a Cleared decision on October 1, 2004, 14 days after receiving the submission on September 17, 2004.

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

Submission Details

510(k) Number	K042525 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	September 17, 2004
Decision Date	October 01, 2004
Days to Decision	14 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF