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) Official FDA 510(k) Summary (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.

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
Combination Product No
PCCP Authorized No
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 465
Devices cleared under the same product code (KPS) and FDA review panel - the closest regulatory comparables to K113754.
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K113754 · CFR QUANT
Download PDF FDA Summary University of Texas M…