Cleared Traditional

K093581 - DISCOVERY MODEL CT590 RT AND OPTIMA MODEL CT580 CT SYSTEMS

K093581 is an FDA 510(k) clearance for DISCOVERY MODEL CT590 RT AND OPTIMA MOD..., manufactured by Ge Medical Systems, LLC. The device is a Class 2 Radiology device with product code JAK cleared through the Traditional 510(k) pathway after a 517-day FDA review.

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

FDA 510(k) Submission Details - K093581

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
Combination Product No
PCCP Authorized No
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.

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 Peers - JAK System, X-ray, Tomography, Computed

All 732
Devices cleared under the same product code (JAK) and FDA review panel - the closest regulatory comparables to K093581.
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