PROBEAT-V Proton Beam Therapy System with X-ray Limiting Accessory— 510(k) K161163
Substantially EquivalentHitachi , Ltd.
FDA 510(k) clearance K161163 for PROBEAT-V Proton Beam Therapy System with X-ray Limiting Accessory, Substantially Equivalent on 2016-07-13. Applicant: Hitachi , Ltd..
Clearance details
- Applicant
- Hitachi , Ltd.
- Product code
- Code LHN
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tokyo, JP
Data sourced from openFDA. This site is unofficial and independent of the FDA.