Cleared Traditional

Optional Screen Display for HeartSee Cardiac P.E.T. Processing Software - HeartSee version 3 (K202679) - FDA 510(k) Clearance

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K202679 · Mcgovern Medical School · Radiology device
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Apr 2021
Decision
209d
Days
Class 2
Risk

K202679 is an FDA 510(k) clearance for the Optional Screen Display for HeartSee Cardiac P.E.T. Processing Software - Hea.... Classified as System, Tomography, Computed, Emission (product code KPS), Class II - Special Controls.

Submitted by Mcgovern Medical School (Houston, US). The FDA issued a Cleared decision on April 12, 2021 after a review of 209 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.

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Submission Details

510(k) Number K202679 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 2020
Decision Date April 12, 2021
Days to Decision 209 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
102d slower than avg
Panel avg: 107d · This submission: 209d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 177
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