Cleared Traditional

K113408 - Q. FREEZE (MOTION VUE2)

K113408 is an FDA 510(k) clearance for Q. FREEZE (MOTION VUE2), manufactured by Ge Medical Systems, LLC. The device is a Class 2 Radiology device with product code KPS cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K113408 · Ge Medical Systems, LLC · Radiology device
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Feb 2012
Decision
98d
Days
Class 2
Risk

K113408 is an FDA 510(k) clearance for the Q. FREEZE (MOTION VUE2). Classified as System, Tomography, Computed, Emission (product code KPS), Class II - Special Controls.

Submitted by Ge Medical Systems, LLC (Waukesha, US). The FDA issued a Cleared decision on February 24, 2012 after a review of 98 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1200 - 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

FDA 510(k) Submission Details - K113408

510(k) Number K113408 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 18, 2011
Decision Date February 24, 2012
Days to Decision 98 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
9d faster than avg
Panel avg: 107d · This submission: 98d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KPS Device Classification - Class 2, Special Controls

Product Code KPS System, Tomography, Computed, Emission
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1200
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 - KPS System, Tomography, Computed, Emission

All 372
Devices cleared under the same product code (KPS) and FDA review panel - the closest regulatory comparables to K113408.
IMAGEN3D
K122241 · Cardiovascular Imaging Technologies · Oct 2012
CFR QUANT
K113754 · University of Texas Medical School AT Houston · Jul 2012
OPTIMA NM/CT 640
K121019 · Ge Healthcare · Apr 2012
ACQA
K113086 · Texas Medical Imaging Consultants · Jan 2012
BIOGRAPH MCT FAMILY
K113448 · Siemens Medical Solutions USA, Inc. · Dec 2011
BRIVO NM 615
K113350 · Ge Healthcare · Dec 2011