Gentuity HF-OCT Imaging System with Vis-Rx Micro-Imaging Catheter— 510(k) K192922
Substantially EquivalentGentuity, LLC
FDA 510(k) clearance K192922 for Gentuity HF-OCT Imaging System with Vis-Rx Micro-Imaging Catheter, Substantially Equivalent on 2020-02-20. Applicant: Gentuity, LLC.
Clearance details
- Applicant
- Gentuity, LLC
- Product code
- Code NQQ
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Sudbury, MA, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.