OARtrac System with Patient Specific Reusable Universal PSD Sensors— 510(k) K162954
Substantially EquivalentRadiadyne, LLC
FDA 510(k) clearance K162954 for OARtrac System with Patient Specific Reusable Universal PSD Sensors, Substantially Equivalent on 2017-06-01. Applicant: Radiadyne, LLC.
Clearance details
- Applicant
- Radiadyne, 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.