Cleared Traditional

CARD EP (K031261) - FDA 510(k) Clearance

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K031261 · GE Medical Systems · Radiology device
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Optimized for regulatory review, auditing and printing
May 2003
Decision
15d
Days
Class 2
Risk

K031261 is an FDA 510(k) clearance for the CARD EP. Classified as System, X-ray, Tomography, Computed (product code JAK), Class II - Special Controls.

Submitted by GE Medical Systems (Milwaukee, US). The FDA issued a Cleared decision on May 6, 2003 after a review of 15 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1750 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all GE Medical Systems devices

Submission Details

510(k) Number K031261 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 107d · This submission: 15d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

Product Code JAK System, X-ray, Tomography, Computed
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1750
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Consultant

Tuv Rheinland of North America, Inc.
HEINZ JOERG STENEBERG

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - JAK System, X-ray, Tomography, Computed

All 429
Devices cleared under the same product code (JAK) and FDA review panel - the closest regulatory comparables to K031261.
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K033418 · Toshiba America Medical Systems, In.C · Nov 2003
PHILIPS PLUS COMPUTED TOMOGRAPHY SYSTEM
K033326 · Philips Medical Systems, Inc. · Oct 2003
AQUILION SUPER 4 MULTISLICE CT SCANNER, MODEL TSX-101A/7
K031469 · Toshiba America Medical Systems, In.C · May 2003
LIGHTSPEED 5.0 COMPUTED TOMOGRAPHY SYSTEM
K030420 · GE Medical Systems · Mar 2003
LUNG NODULE ASSESSMENT AND COMPARISON OPTION
K023785 · Philips Medical Systems (Cleveland), Inc. · Feb 2003
CT CARDIAC FUNCTION ANALYSIS SOFTWARE, MODELS CSCF-001A AND CSCF-001B
K023760 · Toshiba America Medical Systems, In.C · Nov 2002