Caption Interpretation Automated Ejection Fraction Software
FDA 510(k) clearance DEN220063 · decided 2023-02-24
Clearance details
- K-number
- DEN220063
- Device name
- Caption Interpretation Automated Ejection Fraction Software
- Applicant
- Caption Health, Inc.
- Decision
- Unknown
- Date received
- 2022-09-28
- Decision date
- 2023-02-24
- Days to decision
- 149 days
- Clearance type
- Direct
- Product code
- QVD
- Device class
- 2
- Regulation number
- 892.2055
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Brisbane, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.