Caption Interpretation Automated Ejection Fraction Software— 510(k) K200621

Name: FDA 510(k) clearance K200621
Creator: U.S. Food and Drug Administration
Published: 2020-07-22

Substantially Equivalent

Caption Health

FDA 510(k) clearance K200621 for Caption Interpretation Automated Ejection Fraction Software, Substantially Equivalent on 2020-07-22. Applicant: Caption Health. Device class: 2.

Clearance details

Applicant: Caption Health
Product code: Code QIH
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2020-03-09
Decision date: 2020-07-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brisbane, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code QIH

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K260811 — Heartvue.Proton2026-08-26

More clearances from Caption Health

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K210747 — Caption Interpretation Automated Ejection Fraction Software2022-01-19
K201992 — Caption Guidance2020-09-18
K200755 — Caption Guidance2020-04-16

Recalls naming K200621

K-number listed on FDA's recall record

Z-2111-2021 — Version: 1.2.0 (1.2.0+85ela410) Caption Health, Caption AI, Ultrasound Imaging System Application Software (GMDN: 40873), UDI: (01)00860003586303(10)1.2.0)Class II·Terminated·Caption Health·20210519

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K200621.

Data sourced from openFDA. This site is unofficial and independent of the FDA.