Cleared Traditional

CARDIQ EXPRESS VERSION 2.0

K073138 · GE Medical Systems · Radiology
Feb 2008
Decision
111d
Days
Class 2
Risk

About This 510(k) Submission

K073138 is an FDA 510(k) clearance for the CARDIQ EXPRESS VERSION 2.0, a System, X-ray, Tomography, Computed (Class II — Special Controls, product code JAK), submitted by GE Medical Systems (Waukesha, US). The FDA issued a Cleared decision on February 26, 2008, 111 days after receiving the submission on November 7, 2007. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1750.

Submission Details

510(k) Number K073138 FDA.gov
FDA Decision Cleared SESE
Date Received November 07, 2007
Decision Date February 26, 2008
Days to Decision 111 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code JAK — System, X-ray, Tomography, Computed
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1750

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