Cleared Traditional

CARD EP

K031261 · GE Medical Systems · Radiology
May 2003
Decision
15d
Days
Class 2
Risk

About This 510(k) Submission

K031261 is an FDA 510(k) clearance for the CARD EP, a System, X-ray, Tomography, Computed (Class II — Special Controls, product code JAK), submitted by GE Medical Systems (Milwaukee, US). The FDA issued a Cleared decision on May 6, 2003, 15 days after receiving the submission on April 21, 2003. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1750.

Submission Details

510(k) Number K031261 FDA.gov
FDA Decision Cleared SESE
Date Received April 21, 2003
Decision Date May 06, 2003
Days to Decision 15 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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