FDA.reportPublic FDA data

PROBEAT

Primary DI
04560333350440
Brand
PROBEAT
Company
HITACHI HIGH-TECH CORPORATION
Model
PROBEAT-FR
Device description
The PROBEAT-FR is a proton beam irradiation system, which provides a therapeutic proton beam for clinical treatment. It is designed to deliver a proton beam with the prescribed dose, dose distribution and directed to the prescribed patient treatment site. The PROBEAT-FR is a modification to the cleared PROBEAT-CR system, for installation at a different clinical site.
Published
2026-04-01
Public version status
New
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
K232032000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K232032000PROBEAT-FRHitachi, Ltd. Radiation Oncology Systems, Kashiwanoha2024-01-12LHN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04560333350204PreviousGS10
04560333350440PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04560333350204045603333502044560333350204
04560333350440045603333504404560333350440

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
964579244
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04560333350334PROBEATPROBEAT2026-04-01
04560333350341PROBEATPROBEAT WITH MGCS2026-04-01
04560333350358PROBEATPROBEAT WITH DISCRETE SPOT SCANNING SYSTEM2026-04-01
04560333350365PROBEATPROBEAT-V2026-04-01
04560333350372PROBEATEXTENDED RANGE SHIFTER FOR PROBEAT-V2026-04-01
04560333350389PROBEATPROBEAT-V2026-04-01
04560333350396PROBEATPROBEAT-V AND ACCESSORIES2026-04-01
04560333350402PROBEATPROBEAT-V PROTON BEAM THERAPY SYSTEM WITH X-RAY LI2026-04-01
04560333350419PROBEATReal Time Image Gating System for Proton Beam Ther2026-04-01
04560333350426PROBEATMini Ridge Filter and auxiliary functions for PROB2026-04-01
04560333350433PROBEATPROBEAT-CR2026-04-01
04560333350457PROBEATSmall Field Applicator2026-04-01
04560333350464PROBEATSmall Field Applicator2026-04-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00850065937113eMotusEMPNIA INC.LHN2026-09-21
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00850065937212eMotusEMPNIA INC.LHN2026-09-21
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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