FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
Clarius Ejection Fraction AI
K Number: K253593
·
Decision Mar 2, 2026
Classifications
1
FEI Numbers
217
Registration Numbers
217
Same Product Code
303
Applicant Total
12
Review Days
105
Basic Information
- Device Name
- Clarius Ejection Fraction AI
- K Number
- K253593
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Clarius Mobile Health Corp.
- Date Received
- November 17, 2025
- Decision Date
- March 2, 2026
- Product Code
- QIH
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| QIH | Automated Radiological Image Processing Software | FDA class 2 | Radiology |
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Other Clearances by Clarius Mobile Health Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K250226 | Clarius Median Nerve AI | May 8, 2025 | Substantially Equivalent |
| K243853 | Clarius Prostate AI | Apr 16, 2025 | Substantially Equivalent |
| K233955 | Clarius OB AI | Jun 14, 2024 | Substantially Equivalent |
| K232257 | Clarius Bladder AI | Nov 13, 2023 | Substantially Equivalent |
| K232704 | Clarius Ultrasound Scanner | Oct 5, 2023 | Substantially Equivalent |
| K222406 | Clarius AI | Jan 23, 2023 | Substantially Equivalent |
| K213436 | Clarius Ultrasound Scanner | Nov 15, 2021 | Substantially Equivalent |
| K192107 | Clarius Ultrasound Scanner | Aug 29, 2019 | Substantially Equivalent |
| K180799 | Clarius Ultrasound Scanner | May 14, 2018 | Substantially Equivalent |
| K172385 | Clarius Ultrasound System | Sep 14, 2017 | Substantially Equivalent |