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FDA 510(k)

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

K-Number: K202679 · 2021-04-12

ApplicantMcgovern Medical School
Decision Date2021-04-12
Product CodeKPS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Optional Screen Display for HeartSee Cardiac P.E.T. Processing Software - HeartSee version 3 is a medical device manufactured by Mcgovern Medical School. It received FDA 510(k) clearance on 2021-04-12 under approval number K202679. The device is classified under product code KPS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Optional Screen Display for HeartSee Cardiac P.E.T. Processing Software - HeartSee version 3?

Optional Screen Display for HeartSee Cardiac P.E.T. Processing Software - HeartSee version 3 is a medical device that received FDA 510(k) clearance on 2021-04-12. It is manufactured by Mcgovern Medical School. The 510(k) number is K202679.

When was Optional Screen Display for HeartSee Cardiac P.E.T. Processing Software - HeartSee version 3 approved by the FDA?

Optional Screen Display for HeartSee Cardiac P.E.T. Processing Software - HeartSee version 3 received FDA 510(k) clearance on 2021-04-12, under approval number K202679.

What company makes Optional Screen Display for HeartSee Cardiac P.E.T. Processing Software - HeartSee version 3?

Optional Screen Display for HeartSee Cardiac P.E.T. Processing Software - HeartSee version 3 is manufactured by Mcgovern Medical School.

What is the FDA product code for Optional Screen Display for HeartSee Cardiac P.E.T. Processing Software - HeartSee version 3?

The FDA product code for Optional Screen Display for HeartSee Cardiac P.E.T. Processing Software - HeartSee version 3 is KPS.

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Related PubMed Literature

PMID: 42174919 Automating Safety Surveillance for Software-Based Medical Devices: Insights from FDA MAUDE Data. Studies in health technology and informatics (2026) PMID: 41836285 A Case Study of AI-Enabled Software as a Medical Device Cleared by the FDA for Assessing Hemorrhage Risk Index (APPRAISE-HRI) after Trauma. NEJM AI (2025) PMID: 41116086 Eye-tracking-based tablet application for enhanced cognitive assessment: a clinical trial for software as a medical device (SaMD). GeroScience (2025)

Other Devices by Mcgovern Medical School

K231731Optional Screen Displays for HeartSee Cardiac P.E.T. Processing Software - HeartSee version 4

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Official Source

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