Cleared Traditional

K113754 - CFR QUANT

K113754 is an FDA 510(k) clearance for CFR QUANT, manufactured by University of Texas Medical School AT Houston. The device is a Class 2 Radiology device with product code KPS cleared through the Traditional 510(k) pathway after a 211-day FDA review.

K113754 · University of Texas Medical School AT Houston · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2012
Decision
211d
Days
Class 2
Risk

K113754 is an FDA 510(k) clearance for the CFR QUANT. Classified as System, Tomography, Computed, Emission (product code KPS), Class II - Special Controls.

Submitted by University of Texas Medical School AT Houston (Houston, US). The FDA issued a Cleared decision on July 19, 2012 after a review of 211 days - an extended review cycle.

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 University of Texas Medical School AT Houston devices

FDA 510(k) Submission Details - K113754

510(k) Number K113754 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 2011
Decision Date July 19, 2012
Days to Decision 211 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
104d slower than avg
Panel avg: 107d · This submission: 211d
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 269
Devices cleared under the same product code (KPS) and FDA review panel - the closest regulatory comparables to K113754.
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OPTIMA NM/CT 640
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Q. FREEZE (MOTION VUE2)
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BIOGRAPH MCT FAMILY
K113448 · Siemens Medical Solutions USA, Inc. · Dec 2011