Cleared Traditional

K112570 - CENTRICITY CARDIO IMAGING (FDA 510(k) Clearance)

K112570 · Ge Healthcare Integrated IT Solutions · Radiology device

Nov 2011

Decision

85d

Days

Class 2

Risk

K112570 is an FDA 510(k) clearance for the CENTRICITY CARDIO IMAGING. This device is classified as a System, Image Processing, Radiological (Class II - Special Controls, product code LLZ).

Submitted by Ge Healthcare Integrated IT Solutions (Barrington, US). The FDA issued a Cleared decision on November 30, 2011, 85 days after receiving the submission on September 6, 2011.

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

Submission Details

510(k) Number	K112570 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	September 06, 2011
Decision Date	November 30, 2011
Days to Decision	85 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF