Medical Device Manufacturer · CA , Vancouver

Clarius Mobile Health Corp.

12 submissions · 12 cleared · Since 2016
12
Total
12
Cleared
0
Denied

Clarius Mobile Health Corp. — FDA 510(k) Submissions

Clarius Mobile Health Corp. has submitted 12 FDA 510(k) premarket notifications since 2016, of which 12 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include System, Imaging, Pulsed Doppler, Ultrasonic, Automated Radiological Image Processing Software . Use the specialty filter in the sidebar to narrow results.

12 devices
1–12 of 12
Clarius Ejection Fraction AI
K253593 · QIH Automated Radiological... · Radiology
Mar 2026 105d
Clarius Median Nerve AI
K250226 · QIH Automated Radiological... · Radiology
May 2025 101d
Clarius Prostate AI
K243853 · QIH Automated Radiological... · Radiology
Apr 2025 121d
Clarius OB AI
K233955 · IYN System, Imaging, Pulsed... · Radiology
Jun 2024 182d
Clarius Bladder AI
K232257 · QIH Automated Radiological... · Radiology
Nov 2023 108d
Clarius Ultrasound Scanner
K232704 · IYN System, Imaging, Pulsed... · Radiology
Oct 2023 30d
Clarius AI
K222406 · QIH Automated Radiological... · Radiology
Jan 2023 167d
Clarius Ultrasound Scanner
K213436 · IYN System, Imaging, Pulsed... · Radiology
Nov 2021 24d
Clarius Ultrasound Scanner
K192107 · IYN System, Imaging, Pulsed... · Radiology
Aug 2019 24d
Clarius Ultrasound Scanner
K180799 · IYN System, Imaging, Pulsed... · Radiology
May 2018 48d
Clarius Ultrasound System
K172385 · IYN System, Imaging, Pulsed... · Radiology
Sep 2017 37d
Clarius Ultrasound System
K163138 · IYN System, Imaging, Pulsed... · Radiology
Nov 2016 21d
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