cvi42 Auto Imaging Software Application— 510(k) K213998
Substantially EquivalentCircle Cardiovascular Imaging, Inc.
FDA 510(k) clearance K213998 for cvi42 Auto Imaging Software Application, Substantially Equivalent on 2022-07-28. Applicant: Circle Cardiovascular Imaging, Inc.. Device class: 2.
Clearance details
- Applicant
- Circle Cardiovascular Imaging, Inc.
- Product code
- Code QIH
- Device class
- Class 2
- Regulation
- 21 CFR 892.2050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Calgary, CA
Recent devices under product code QIH
view allMore clearances from Circle Cardiovascular Imaging, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.