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FDA 510(k), K162246, ProNova SC360 Proton Therapy System
FDA 510(k), K162246, ProNova SC360 Proton Therapy System
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510(K) Number: K162246
Device Name: ProNova SC360 Proton Therapy System
Manufacturer: ADAM KUHN
Device Classification Name: System, Radiation Therapy, Charged-Particle, Medical
Regulation Number: LHN
Classification Product Code: KXA
Date Received: 08/10/2016
Decision Date: 12/08/2016
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Radiology
Device Name: ProNova SC360 Proton Therapy System
Manufacturer: ADAM KUHN
Device Classification Name: System, Radiation Therapy, Charged-Particle, Medical
Regulation Number: LHN
Classification Product Code: KXA
Date Received: 08/10/2016
Decision Date: 12/08/2016
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Radiology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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