ImagenUniversal— 510(k) K173547
Substantially EquivalentCardiovascular Imaging Technologies
FDA 510(k) clearance K173547 for ImagenUniversal, Substantially Equivalent on 2018-01-12. Applicant: Cardiovascular Imaging Technologies.
Clearance details
- Applicant
- Cardiovascular Imaging Technologies
- Product code
- Code KPS
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Kansas City, UT, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.