S250-FIT Proton Beam Radiation Therapy Device (S250-FIT)— 510(k) K250986

Substantially Equivalent

Mevion Medical Systems, Inc.

FDA 510(k) clearance K250986 for S250-FIT Proton Beam Radiation Therapy Device (S250-FIT), Substantially Equivalent on 2025-09-12. Applicant: Mevion Medical Systems, Inc..

Clearance details

Applicant
Mevion Medical Systems, Inc.
Product code
Code LHN
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Littleton, MA, US
Download summary PDFView on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.