Cleared Traditional

DISCOVERY MODEL CT590 RT AND OPTIMA MODEL CT580 CT SYSTEMS (K093581) - FDA 510(k) Clearance

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

K093581 · Ge Medical Systems, LLC · Radiology device
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Apr 2011
Decision
517d
Days
Class 2
Risk

K093581 is an FDA 510(k) clearance for the DISCOVERY MODEL CT590 RT AND OPTIMA MODEL CT580 CT SYSTEMS. 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, 2011 after a review of 517 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Radiology submissions.

View all Ge Medical Systems, LLC devices

Submission Details

510(k) Number K093581 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 18, 2009
Decision Date April 19, 2011
Days to Decision 517 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
410d slower than avg
Panel avg: 107d · This submission: 517d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 352
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