Company profile

Clarius Mobile Health Corp.

Clarius Mobile Health Corp. has 12 AI-enabled medical devices on the FDA list. The first decision was on November 30, 2016 and the most recent on March 2, 2026 (Clarius Ejection Fraction AI). Its most common review panel is Radiology (12 devices).

12AI devices

2016First decision

2026Latest decision

1Specialties

Per year

201620172018201920212023202420252026

Clarius Mobile Health Corp. AI devices per year: 2016 1, 2017 1, 2018 1, 2019 1, 2021 1, 2023 3, 2024 1, 2025 2, 2026 1

By specialty

Radiology12

Related guides

Top radiology devices

Timeline

March 2, 2026 · 510(k) K253593Clarius Ejection Fraction AI · Radiology · QIH
May 8, 2025 · 510(k) K250226Clarius Median Nerve AI · Radiology · QIH
April 16, 2025 · 510(k) K243853Clarius Prostate AI · Radiology · QIH
June 14, 2024 · 510(k) K233955Clarius OB AI · Radiology · IYN
November 13, 2023 · 510(k) K232257Clarius Bladder AI · Radiology · QIH
October 5, 2023 · 510(k) K232704Clarius Ultrasound Scanner · Radiology · IYN
January 23, 2023 · 510(k) K222406Clarius AI · Radiology · QIH
November 15, 2021 · 510(k) K213436Clarius Ultrasound Scanner · Radiology · IYN
August 29, 2019 · 510(k) K192107Clarius Ultrasound Scanner · Radiology · IYN
May 14, 2018 · 510(k) K180799Clarius Ultrasound Scanner · Radiology · IYN
September 14, 2017 · 510(k) K172385Clarius Ultrasound System · Radiology · IYN
November 30, 2016 · 510(k) K163138Clarius Ultrasound System · Radiology · IYN