K232661
- 510(k) number
- K232661
- Device name
- Myocardial Strain Software Application
- Applicant
- Circle Cardiovascular Imaging CA
- Product code
- LLZ — System, Image Processing, Radiological
- Decision date
- 2023-12-07
- Date received
- 2023-08-31
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
510(k) Summary (official FDA PDF): K232661.pdf
Official FDA record: K232661
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.