ProBeam 360 Proton Therapy System - Rotating Gantry

Primary DI
00858991006194
Brand
ProBeam 360 Proton Therapy System - Rotating Gantry
Company
Varian Medical Systems Particle Therapy GmbH & Co. KG
Model
3.0
Published
2026-04-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
K252815000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K252815000ProBeam 360 Proton Therapy System v3.0Varian Medical Systems, Inc.2026-04-23LHN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00858991006194PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00858991006194008589910061948589910061940858991006194

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.

Regulatory Flags#

DUNS number
342623907
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00858991006132ProBeam Proton Therapy System - Rotating Gantry4.3 MR62025-04-29
00858991006149ProBeam Proton Therapy System - Fixed Beam Room4.3 MR62025-04-29
00858991006088ProBeam 360 Proton Therapy System - Rotating Gantry2.02023-10-25
00858991006071ProBeam 360 Proton Therapy System - Rotaiting Gantry1.02022-12-06
00858991006064ProBeam® Proton Therapy System - Fixed Beam Room4.32021-09-30
00858991006057ProBeam® Proton Therapy System - Rotating Gantry4.32021-07-01
00858991006026ProBeam® Fixed Beam Proton Therapy System3.52019-09-12
00858991006033ProBeam® Rotating Gantry Proton Therapy System3.52019-09-12
00858991006040ProBeam® Rotating Gantry Proton Therapy System4.22019-09-12
00858991006002ProBeam Proton Therapy System3.02016-09-21
00858991006019ProBeam Proton Therapy System3.02016-09-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00864366000148MEVION S250-FIT Proton Therapy SystemMEVION MEDICAL SYSTEMS, INC.LHN2026-05-04
00864366000117MEVION S250-FIT Proton Therapy SystemMEVION MEDICAL SYSTEMS, INC.LHN2026-04-30
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EPTWTM310250PinPointPTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbHLHN2026-04-14
EPTWTN310240SemiflexPTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbHLHN2026-04-14
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