Cleared Traditional

K171303 - Added Screen Displays For FDA Cleared HeartSee Cardiac P.E.T Processing Software K143664

K171303 is an FDA 510(k) clearance for Added Screen Displays For FDA Cleared H..., manufactured by University of Texas Medical School AT Houston, Texas. The device is a Class 2 Radiology device with product code KPS cleared through the Traditional 510(k) pathway after a 142-day FDA review.

K171303 · University of Texas Medical School AT Houston, Texas · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2017
Decision
142d
Days
Class 2
Risk

K171303 is an FDA 510(k) clearance for the Added Screen Displays For FDA Cleared HeartSee Cardiac P.E.T Processing Softw.... Classified as System, Tomography, Computed, Emission (product code KPS), Class II - Special Controls.

Submitted by University of Texas Medical School AT Houston, Texas (Houston, US). The FDA issued a Cleared decision on September 22, 2017 after a review of 142 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.

FDA 510(k) Submission Details - K171303

510(k) Number K171303 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 03, 2017
Decision Date September 22, 2017
Days to Decision 142 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
35d slower than avg
Panel avg: 107d · This submission: 142d
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 440
Devices cleared under the same product code (KPS) and FDA review panel - the closest regulatory comparables to K171303.
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