Aorta-CAD— 510(k) K213353
Substantially EquivalentImagen Technologies, Inc.
FDA 510(k) clearance K213353 for Aorta-CAD, Substantially Equivalent on 2022-09-20. Applicant: Imagen Technologies, Inc..
Clearance details
- Applicant
- Imagen Technologies, Inc.
- Product code
- Code MYN
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- New York, NY, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.