Clarius Mobile Health Corp
Vancouver British Columbia, CA
CLARIUS MOBILE HEALTH CORP. appears in FDA device records in Vancouver British Columbia, CA. FDA records list 12 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 12 510(k) clearances for Clarius Mobile Health Corp between 2016 and 2026. The busiest year on record is 2023, with 3. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2016 | 1 |
| 2017 | 1 |
| 2018 | 1 |
| 2019 | 1 |
| 2021 | 1 |
| 2023 | 3 |
| 2024 | 1 |
| 2025 | 2 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K253593 | Clarius Ejection Fraction AI | QIH | Substantially Equivalent | |
| K250226 | Clarius Median Nerve AI | QIH | Substantially Equivalent | |
| K243853 | Clarius Prostate AI | QIH | Substantially Equivalent | |
| K233955 | Clarius OB AI | IYN | Substantially Equivalent | |
| K232257 | Clarius Bladder AI | QIH | Substantially Equivalent | |
| K232704 | Clarius Ultrasound Scanner | IYN | Substantially Equivalent | |
| K222406 | Clarius AI | QIH | Substantially Equivalent | |
| K213436 | Clarius Ultrasound Scanner | IYN | Substantially Equivalent | |
| K192107 | Clarius Ultrasound Scanner | IYN | Substantially Equivalent | |
| K180799 | Clarius Ultrasound Scanner | IYN | Substantially Equivalent | |
| K172385 | Clarius Ultrasound System | IYN | Substantially Equivalent | |
| K163138 | Clarius Ultrasound System | IYN | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3012747207 | 3012747207 | CLARIUS MOBILE HEALTH CORP. | 205-2980 Virtual Way, Vancouver British Columbia V5M 4X3 CA | 2026 | |
| 3016427557 | 3016427557 | Clarius Mobile Health Corp | 1375 Stonegate Way, Ferndale, WA 98248 US | 2026 | No device listings on this registration |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain