Cleared Traditional

CENTRICITY PACS PLUS

K023557 · GE Medical Systems · Radiology
Nov 2002
Decision
15d
Days
Class 2
Risk

About This 510(k) Submission

K023557 is an FDA 510(k) clearance for the CENTRICITY PACS PLUS, a System, Image Processing, Radiological (Class II — Special Controls, product code LLZ), submitted by GE Medical Systems (Mount Prospect, US). The FDA issued a Cleared decision on November 7, 2002, 15 days after receiving the submission on October 23, 2002. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K023557 FDA.gov
FDA Decision Cleared SESE
Date Received October 23, 2002
Decision Date November 07, 2002
Days to Decision 15 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code LLZ — System, Image Processing, Radiological
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.2050