Cleared Special

LIGHTSPEED ULTRA COMPUTED TOMOGRAPHY SYSTEM WITH WIDE-VIEW (K023332) - FDA 510(k) Clearance

Class II Radiology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K023332 · GE Medical Systems · Radiology device
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Oct 2002
Decision
16d
Days
Class 2
Risk

K023332 is an FDA 510(k) clearance for the LIGHTSPEED ULTRA COMPUTED TOMOGRAPHY SYSTEM WITH WIDE-VIEW. 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 23, 2002 after a review of 16 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all GE Medical Systems devices

Submission Details

510(k) Number K023332 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 07, 2002
Decision Date October 23, 2002
Days to Decision 16 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
91d faster than avg
Panel avg: 107d · This submission: 16d
Pathway characteristics
Modification to existing cleared device.

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 429
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