Cleared Traditional

K013422 - CARDIQ FUNCTION

K013422 is an FDA 510(k) clearance for CARDIQ FUNCTION, manufactured by GE Medical Systems. The device is a Class 2 Radiology device with product code JAK cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K013422 · GE Medical Systems · Radiology device
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Optimized for regulatory review, auditing and printing
Oct 2001
Decision
15d
Days
Class 2
Risk

K013422 is an FDA 510(k) clearance for the CARDIQ FUNCTION. Classified as System, X-ray, Tomography, Computed (product code JAK), Class II - Special Controls.

Submitted by GE Medical Systems (Waukesha, US). The FDA issued a Cleared decision on October 30, 2001 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

FDA 510(k) Submission Details - K013422

510(k) Number K013422 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 2001
Decision Date October 30, 2001
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.

JAK Device Classification - Class 2, Special Controls

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.
REINER KRUMME

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 639
Devices cleared under the same product code (JAK) and FDA review panel - the closest regulatory comparables to K013422.
LIGHTSPEED 4.0 CT SCANNER SYSTEM
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GEMINI IMAGING SYSTEM
K013521 · Adac Laboratories · Nov 2001
SOMATOM P30 CT SYSTEMS
K013522 · Siemens Medical Systems, Inc. · Nov 2001
ADVANCED LUNG ANALYSIS-1
K013381 · General Electric Co. · Oct 2001
CEREBRAL BLOOD FLOW ANALYSIS SYSTEM (CBP), MODEL NUMBER CSCP-001A
K013214 · Toshiba America Medical Systems, In.C · Oct 2001
DOSERIGHT
K012238 · Philips Medical Systems North America Co. · Oct 2001