Company profile

Caption Health

Caption Health has 4 AI-enabled medical devices on the FDA list. The first decision was on April 16, 2020 and the most recent on January 19, 2022 (Caption Interpretation Automated Ejection Fraction Software). Its most common review panel is Radiology (4 devices).

4AI devices

2020First decision

2022Latest decision

1Specialties

Per year

20202022

Caption Health AI devices per year: 2020 3, 2022 1

By specialty

Radiology4

Related guides

Top radiology devices

Timeline

January 19, 2022 · 510(k) K210747Caption Interpretation Automated Ejection Fraction Software · Radiology · QIH
September 18, 2020 · 510(k) K201992Caption Guidance · Radiology · QJU
July 22, 2020 · 510(k) K200621Caption Interpretation Automated Ejection Fraction Software · Radiology · QIH
April 16, 2020 · 510(k) K200755Caption Guidance · Radiology · QJU