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510(k) Data Aggregation

K Number

Device Name

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

Manufacturer

Mevion Medical Systems, Inc.

Date Cleared

2025-09-12

(165 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Why did this record match?

Applicant Name (Manufacturer) :

Mevion Medical Systems, Inc.

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

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