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510(k) K231731

Optional Screen Displays for HeartSee Cardiac P.E.T. Processing Software - HeartSee version 4 by Mcgovern Medical School — Product Code KPS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 21, 2023
Date Received
June 13, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Tomography, Computed, Emission
Device Class
Class II
Regulation Number
892.1200
Review Panel
RA
Submission Type

Other clearances by Mcgovern Medical School

  • K202679 — Optional Screen Display for HeartSee Cardiac P.E.T. Processing Software - HeartS (April 12, 2021)

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