Cleared Traditional

K163213 - Revolution CT

K163213 is the FDA 510(k) clearance for Revolution CT by Ge Medical Systems, LLC. It is a Class 2 Radiology device (product code JAK) cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K163213 · Ge Medical Systems, LLC · Radiology device
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Dec 2016
Decision
30d
Days
Class 2
Risk

K163213 is an FDA 510(k) clearance for the Revolution CT. 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 December 16, 2016 after a review of 30 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, LLC devices

Submission Details

510(k) Number K163213 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 16, 2016
Decision Date December 16, 2016
Days to Decision 30 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
77d faster than avg
Panel avg: 107d · This submission: 30d
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 593
Devices cleared under the same product code (JAK) and FDA review panel - the closest regulatory comparables to K163213.
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Vitrea CT Dual Energy Image View
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OnSight 3D Extremity System
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SOMATOM Drive
K161196 · Siemens Medical Solutions USA, Inc. · Aug 2016