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FDA 510(k)

Caption Interpretation Automated Ejection Fraction Software

K-Number: K200621 · 2020-07-22

ApplicantCaption Health
Decision Date2020-07-22
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Caption Interpretation Automated Ejection Fraction Software is a medical device manufactured by Caption Health. It received FDA 510(k) clearance on 2020-07-22 under approval number K200621. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Caption Interpretation Automated Ejection Fraction Software?

Caption Interpretation Automated Ejection Fraction Software is a medical device that received FDA 510(k) clearance on 2020-07-22. It is manufactured by Caption Health. The 510(k) number is K200621.

When was Caption Interpretation Automated Ejection Fraction Software approved by the FDA?

Caption Interpretation Automated Ejection Fraction Software received FDA 510(k) clearance on 2020-07-22, under approval number K200621.

What company makes Caption Interpretation Automated Ejection Fraction Software?

Caption Interpretation Automated Ejection Fraction Software is manufactured by Caption Health.

What is the FDA product code for Caption Interpretation Automated Ejection Fraction Software?

The FDA product code for Caption Interpretation Automated Ejection Fraction Software is QIH.

Related Clinical Trials

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Related PubMed Literature

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: 40714034 Relationship between industry payments to physicians and prescription patterns for PCSK9is, ARNis and DOACs: A report from the NCDR PINNACLE registry. American heart journal (2026)

Other Devices by Caption Health

K201992Caption Guidance K200755Caption Guidance K210747Caption Interpretation Automated Ejection Fraction Software

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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