FDA.reportPublic FDA data

MEVION S250i

Primary DI
00864366000124
Brand
MEVION S250i
Company
MEVION MEDICAL SYSTEMS, INC.
Model
S250i
Catalog number
MEVION S250i
Published
2018-02-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
LHNSystem, Radiation Therapy, Charged-Particle, Medical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LHNSystem, Radiation Therapy, Charged-Particle, MedicalRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K172848000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K172848000MEVION S250i Proton Beam Radiation Therapy DeviceMevion Medical Systems2017-12-27LHN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00864366000124PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00864366000124008643660001248643660001240864366000124

GMDN Terms#

Term, Definition table
TermDefinition
Proton therapy systemAn assembly of devices/sub-systems designed to produce and deliver a transverse- and longitudinal-dose proton beam to treat localized tumours and other conditions susceptible to treatment by radiation. It typically consists of components for beam production, transport and delivery; patient positioning; system and component control; and software. It will typically be configured to a particular site’s requirements.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity30 Percent (%) Relative Humidity70 Percent (%) Relative Humidity
Storage Environment Temperature66 Degrees Fahrenheit74 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
199652145
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00864366000148MEVION S250-FIT Proton Therapy SystemS250-FIT-VISS250-FIT-VIS2026-05-04
00864366000117MEVION S250-FIT Proton Therapy SystemS250-FITS250-FIT2026-04-30
00864366000100Mevion Medical SystemsS250MEVION S2502016-05-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850065937007eMotusEMPNIA INC.LHN2026-09-21
00850065937014eMotusEMPNIA INC.LHN2026-09-21
00850065937021eMotusEMPNIA INC.LHN2026-09-21
00850065937038eMotusEMPNIA INC.LHN2026-09-21
00850065937045eMotusEMPNIA INC.LHN2026-09-21
00850065937052eMotusEMPNIA INC.LHN2026-09-21
00850065937069eMotusEMPNIA INC.LHN2026-09-21
00850065937076eMotusEMPNIA INC.LHN2026-09-21
00850065937083eMotusEMPNIA INC.LHN2026-09-21
00850065937090eMotusEMPNIA INC.LHN2026-09-21
00850065937106eMotusEMPNIA INC.LHN2026-09-21
00850065937113eMotusEMPNIA INC.LHN2026-09-21
00850065937120eMotusEMPNIA INC.LHN2026-09-21
00850065937137eMotusEMPNIA INC.LHN2026-09-21
00850065937144eMotusEMPNIA INC.LHN2026-09-21
00850065937151eMotusEMPNIA INC.LHN2026-09-21
00850065937168eMotusEMPNIA INC.LHN2026-09-21
00850065937175eMotusEMPNIA INC.LHN2026-09-21
00850065937182eMotusEMPNIA INC.LHN2026-09-21
00850065937199eMotusEMPNIA INC.LHN2026-09-21
00850065937205eMotusEMPNIA INC.LHN2026-09-21
00850065937212eMotusEMPNIA INC.LHN2026-09-21
00850065937229eMotusEMPNIA INC.LHN2026-09-21
00850065937236eMotusEMPNIA INC.LHN2026-09-21
00850065937243eMotusEMPNIA INC.LHN2026-09-21
00850065937250eMotusEMPNIA INC.LHN2026-09-21
00850065937267eMotusEMPNIA INC.LHN2026-09-21
00850065937274eMotusEMPNIA INC.LHN2026-09-21
00850065937298eMotusEMPNIA INC.LHN2026-09-21
00850065937304eMotusEMPNIA INC.LHN2026-09-21