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Clarius Mobile Health Corp.

FDA 510(k) & PMA Approved Devices — 12 products

Total Devices12
Categories2
Latest Approval2026-03-02
TypeNumberDevice NameCodeDate
510(k) K253593 Clarius Ejection Fraction AI QIH 2026-03-02 View
510(k) K250226 Clarius Median Nerve AI QIH 2025-05-08 View
510(k) K243853 Clarius Prostate AI QIH 2025-04-16 View
510(k) K233955 Clarius OB AI IYN 2024-06-14 View
510(k) K232257 Clarius Bladder AI QIH 2023-11-13 View
510(k) K232704 Clarius Ultrasound Scanner IYN 2023-10-05 View
510(k) K222406 Clarius AI QIH 2023-01-23 View
510(k) K213436 Clarius Ultrasound Scanner IYN 2021-11-15 View
510(k) K192107 Clarius Ultrasound Scanner IYN 2019-08-29 View
510(k) K180799 Clarius Ultrasound Scanner IYN 2018-05-14 View
510(k) K172385 Clarius Ultrasound System IYN 2017-09-14 View
510(k) K163138 Clarius Ultrasound System IYN 2016-11-30 View
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