FDA.reportPublic FDA data

PROBEAT

Primary DI
04560333350372
Brand
PROBEAT
Company
HITACHI HIGH-TECH CORPORATION
Model
EXTENDED RANGE SHIFTER FOR PROBEAT-V
Device description
The Extended Range Shifter is an accessory to the PROBEAT-V system that is intended to assist the radiation oncologist in the delivery of proton radiation to defined target volumes while sparing surrounding normal tissue and critical organs from excess radiation.
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
K152207000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K152207000Extended Range Shifter for PROBEAT-VHitachi, Ltd., Health Care Company2015-10-02LHN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04560333350372PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04560333350372045603333503724560333350372

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
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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00850065937250eMotusEMPNIA INC.LHN2026-09-21
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00850065937304eMotusEMPNIA INC.LHN2026-09-21