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FDA 510(k), K172848, MEVION S250i Proton Beam Radiation Therapy Device
FDA 510(k), K172848, MEVION S250i Proton Beam Radiation Therapy Device
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510(K) Number: K172848
Device Name: MEVION S250i Proton Beam Radiation Therapy Device
Manufacturer: Mevion Medical Systems
Device Classification Name: system, radiation therapy, charged-particle, medical
Regulation Number: 892.5050
Classification Product Code: LHN
Date Received: 09/19/2017
Decision Date: 12/27/2017
Regulation Medical Specialty: Radiology
Device Name: MEVION S250i Proton Beam Radiation Therapy Device
Manufacturer: Mevion Medical Systems
Device Classification Name: system, radiation therapy, charged-particle, medical
Regulation Number: 892.5050
Classification Product Code: LHN
Date Received: 09/19/2017
Decision Date: 12/27/2017
Regulation Medical Specialty: Radiology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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