K253406

Substantially Equivalent

S250-FIT Proton Beam Radiation Therapy Device (S250-FIT)

Applicant: Mevion Medical Systems, Inc.
Product code: LHN
Advisory panel: Radiology
Date received: 2025-09-30
Decision date: 2026-03-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Littleton, MA, US

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