Mcgovern Medical School

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
2
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K231731Optional Screen Displays for HeartSee Cardiac P.E.T. Processing Software - HeartSee version 4August 21, 2023
K202679Optional Screen Display for HeartSee Cardiac P.E.T. Processing Software - HeartSee version 3April 12, 2021