FDA.reportPublic FDA data

PROBEAT

Primary DI
04560333350358
Brand
PROBEAT
Company
HITACHI HIGH-TECH CORPORATION
Model
PROBEAT WITH DISCRETE SPOT SCANNING SYSTEM
Device description
"The PROBEAT with DSSS is a medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation. The only difference between the PROBEAT with DSSS and the cleared PROBEAT is the addition of the Discrete Spot Scanning System (""DSSS""). "
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
K073059000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K073059000PROBEAT WITH DISCRETE SPOT SCANNING SYSTEMHitachi, Ltd., Power Systems Group2007-12-10LHN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04560333350358PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04560333350358045603333503584560333350358

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
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
04560333350440PROBEATPROBEAT-FR2026-04-01
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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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