HeartSee Cardiac P.E.T. Processing Software— 510(k) K181343
Substantially EquivalentBracco Diagnostics, Inc.
FDA 510(k) clearance K181343 for HeartSee Cardiac P.E.T. Processing Software, Substantially Equivalent on 2018-06-12. Applicant: Bracco Diagnostics, Inc..
Clearance details
- Applicant
- Bracco Diagnostics, Inc.
- Product code
- Code KPS
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Monroe Township, NE, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.