OARtrac System— 510(k) K182395
Substantially EquivalentRadialdyne, LLC
FDA 510(k) clearance K182395 for OARtrac System, Substantially Equivalent on 2019-03-22. Applicant: Radialdyne, LLC.
Clearance details
- Applicant
- Radialdyne, LLC
- Product code
- Code NZT
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Houston, TX, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.