Cleared Traditional

K043415 - CENTRICITY PACS SYSTEM (FDA 510(k) Clearance)

K043415 · Ge Medical Systems Information Technologies · Radiology device

Jan 2005

Decision

39d

Days

Class 2

Risk

K043415 is an FDA 510(k) clearance for the CENTRICITY PACS SYSTEM. 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 January 21, 2005, 39 days after receiving the submission on December 13, 2004.

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

Submission Details

510(k) Number	K043415 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	December 13, 2004
Decision Date	January 21, 2005
Days to Decision	39 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF