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

Name: FDA 510(k) clearance K202679
Creator: U.S. Food and Drug Administration
Published: 2021-04-12

Substantially Equivalent

Mcgovern Medical School

FDA 510(k) clearance K202679 for Optional Screen Display for HeartSee Cardiac P.E.T. Processing Software - HeartSee version 3, Substantially Equivalent on 2021-04-12. Applicant: Mcgovern Medical School. Device class: 2.

Clearance details

Applicant: Mcgovern Medical School
Product code: Code KPS
Device class: Class 2
Regulation: 21 CFR 892.1200
Advisory panel: Radiology
Date received: 2020-09-15
Decision date: 2021-04-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Houston, TX, US

Download summary PDF View on FDA.gov ↗

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