ViZion DR + Wireless— 510(k) K160810
Substantially EquivalentViztek, LLC
FDA 510(k) clearance K160810 for ViZion DR + Wireless, Substantially Equivalent on 2016-05-20. Applicant: Viztek, LLC. Device class: 2.
Clearance details
- Applicant
- Viztek, LLC
- Product code
- Code MQB
- Device class
- Class 2
- Regulation
- 21 CFR 892.1680
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Garner, NC, US
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