510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K202679Substantially Equivalent

Optional Screen Display for HeartSee Cardiac P.E.T. Processing Software - HeartSee version 3

Mcgovern Medical School, Houston TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K202679 is the FDA 510(k) clearance record for Optional Screen Display for HeartSee Cardiac P.E.T. Processing Software - HeartSee version 3, a class II device, cleared for Mcgovern Medical School on under FDA product code KPS (System, Tomography, Computed, Emission). FDA records list 2 510(k) clearances for Mcgovern Medical School, from to . As of , FDA records show no recalls naming K202679.

Clearance record

Decision date
Received
(209 days to decision)
Product code
KPS System, Tomography, Computed, Emission
Regulation
21 CFR 892.1200
Device class
Class II
Review panel
Radiology
Applicant
Mcgovern Medical School 6431 Fannin St., Msb 4.256, Houston TX
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KPS

Trailing 12 months
9 clearances under product code KPS in the twelve months to October 2026, December 2025 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code KPS, trailing twelve months
MonthClearances
November 20251
December 20252
January 20261
February 20261
March 20260
April 20261
May 20261
June 20260
July 20261
August 20260
September 20261
October 20260