K241038
- 510(k) number
- K241038
- Device name
- Cardiac CT Function Software Application
- Applicant
- Circle Cardiovascular Imaging CA
- Product code
- QIH — Automated Radiological Image Processing Software
- Decision date
- 2024-06-07
- Date received
- 2024-04-16
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K241038.pdf
Official FDA record: K241038
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.