Cleared Traditional

K073153 - CARDIQ FUNCTION XPRESS

K073153 is the FDA 510(k) clearance for CARDIQ FUNCTION XPRESS by GE Medical Systems SCS. It is a Class 2 Radiology device (product code JAK) cleared through the Traditional 510(k) pathway after a 110-day FDA review.

K073153 · GE Medical Systems SCS · Radiology device
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Feb 2008
Decision
110d
Days
Class 2
Risk

K073153 is an FDA 510(k) clearance for the CARDIQ FUNCTION XPRESS. Classified as System, X-ray, Tomography, Computed (product code JAK), Class II - Special Controls.

Submitted by GE Medical Systems SCS (Buc Cedex, FR). The FDA issued a Cleared decision on February 26, 2008 after a review of 110 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all GE Medical Systems SCS devices

Submission Details

510(k) Number K073153 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 08, 2007
Decision Date February 26, 2008
Days to Decision 110 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
3d slower than avg
Panel avg: 107d · This submission: 110d
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

Intertek Testing Services
JAY Y KOGOMA

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 604
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K073373 · Siemens AG Medical Solutions · Dec 2007