# Clarius Mobile Health Corp.

- Location (FDA's records): Vancouver, CA
- FDA decisions: 12 (2016–2026): 12 510(k) clearances
- Product codes: IYN (7), QIH (5)
- 510(k) review time since 2016: median 75 days, against 117 for FDA's reviews in the same codes and years (10 of 12 faster)
- Predicates its devices cite: 16 (7 its own); citations of its devices by later devices: 19 (7 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- FUJIFILM Sonosite, Inc.: 2 (https://510kreport.com/company/fujifilm-sonosite)
- Siemens Healthcare GmbH: 1 (https://510kreport.com/company/siemens-healthcare)
- Exo, Inc.: 1 (https://510kreport.com/company/exo)
- Dia Imaging Analysis, Ltd.: 1 (https://510kreport.com/company/dia-imaging-analysis)
- Caption Health: 1 (https://510kreport.com/company/caption-health)
- Healcerion Co., Ltd.: 1 (https://510kreport.com/company/healcerion)
- Philips Healthcare, Inc.: 1 (https://510kreport.com/company/philips-healthcare)
- Sonio: 1 (https://510kreport.com/company/sonio)

## Firms that cite its devices most
- Healcerion Co., Ltd.: 3 (https://510kreport.com/company/healcerion)
- Aco Healthcare Co., Ltd.: 2 (https://510kreport.com/company/aco-healthcare)
- Imacor, Inc.: 1 (https://510kreport.com/company/imacor)
- Compal Electronics, Inc.: 1 (https://510kreport.com/company/compal-electronics)
- Leltek, Inc.: 1 (https://510kreport.com/company/leltek)
- Guangdong Youkey Medical Co., Ltd.: 1 (https://510kreport.com/company/guangdong-youkey-medical)
- Biim Ultrasound AS: 1 (https://510kreport.com/company/biim-ultrasound)
- ROPCA ApS: 1 (https://510kreport.com/company/ropca)

## Its most-cited devices
- K192107: Clarius Ultrasound Scanner (2019), cited by 7
- K222406: Clarius AI (2023), cited by 3
- K163138: Clarius Ultrasound System (2016), cited by 3
- K172385: Clarius Ultrasound System (2017), cited by 2
- K213436: Clarius Ultrasound Scanner (2021), cited by 2
- K180799: Clarius Ultrasound Scanner (2018), cited by 1

## Recent decisions
- K253593: Clarius Ejection Fraction AI (Mar 2, 2026)
- K250226: Clarius Median Nerve AI (May 8, 2025)
- K243853: Clarius Prostate AI (Apr 16, 2025)
- K233955: Clarius OB AI (Jun 14, 2024)
- K232257: Clarius Bladder AI (Nov 13, 2023)
- K232704: Clarius Ultrasound Scanner (Oct 5, 2023)
- K222406: Clarius AI (Jan 23, 2023)
- K213436: Clarius Ultrasound Scanner (Nov 15, 2021)

Source page: https://510kreport.com/company/clarius-mobile-health