Radiance 330 Proton Beam Therapy System— 510(k) K191521
Substantially EquivalentProtom International Holding Corporation
FDA 510(k) clearance K191521 for Radiance 330 Proton Beam Therapy System, Substantially Equivalent on 2019-09-27. Applicant: Protom International Holding Corporation. Device class: 2.
Clearance details
- Applicant
- Protom International Holding Corporation
- Product code
- Code LHN
- Device class
- Class 2
- Regulation
- 21 CFR 892.5050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Wakefield, MA, US
Recent devices under product code LHN
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