Cleared Traditional

GE LIGHTSPEED XTRA CT SCANNER SYSTEM (K060052) - FDA 510(k) Clearance

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

K060052 · Ge Medical Systems, LLC · Radiology device
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Apr 2006
Decision
103d
Days
Class 2
Risk

K060052 is an FDA 510(k) clearance for the GE LIGHTSPEED XTRA CT SCANNER SYSTEM. Classified as System, X-ray, Tomography, Computed (product code JAK), Class II - Special Controls.

Submitted by Ge Medical Systems, LLC (Waukesha, US). The FDA issued a Cleared decision on April 19, 2006 after a review of 103 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, LLC devices

Submission Details

510(k) Number K060052 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 06, 2006
Decision Date April 19, 2006
Days to Decision 103 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
4d faster than avg
Panel avg: 107d · This submission: 103d
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 Peers - JAK System, X-ray, Tomography, Computed

All 385
Devices cleared under the same product code (JAK) and FDA review panel - the closest regulatory comparables to K060052.
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K061370 · Ge Healthcare · May 2006
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K060779 · Ge Healthcare · Apr 2006
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K052839 · Ge Healthcare · Mar 2006
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K052855 · Ge Healthcare · Oct 2005