FDA.reportPublic FDA data

PROBEAT

Primary DI
04560333350402
Brand
PROBEAT
Company
HITACHI HIGH-TECH CORPORATION
Model
PROBEAT-V PROTON BEAM THERAPY SYSTEM WITH X-RAY LI
Device description
The PROBEAT-V with X-ray Limiting Accessory 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.
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
K161163000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K161163000PROBEAT-V Proton Beam Therapy System with X-ray Limiting AccessoryHitachi , Ltd.2016-07-13LHN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04560333350402PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04560333350402045603333504024560333350402

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
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
00864366000148MEVION S250-FIT Proton Therapy SystemMEVION MEDICAL SYSTEMS, INC.LHN2026-05-04
00864366000117MEVION S250-FIT Proton Therapy SystemMEVION MEDICAL SYSTEMS, INC.LHN2026-04-30
00858991006194ProBeam 360 Proton Therapy System - Rotating GantryVarian Medical Systems Particle Therapy GmbH & Co. KGLHN2026-04-29
EPTWTM310220PinPointPTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbHLHN2026-04-15
EPTWTN310220PinPointPTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbHLHN2026-04-15
EPTWTW310220PinPointPTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbHLHN2026-04-15
EPTWTM310240SemiflexPTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbHLHN2026-04-14
EPTWTM310250PinPointPTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbHLHN2026-04-14
EPTWTN310240SemiflexPTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbHLHN2026-04-14
EPTWTN310250PinPointPTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbHLHN2026-04-14
EPTWTW310240SemiflexPTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbHLHN2026-04-14
EPTWTW310250PinPointPTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbHLHN2026-04-14
04560333350334PROBEATHITACHI HIGH-TECH CORPORATIONLHN2026-04-01
04560333350341PROBEATHITACHI HIGH-TECH CORPORATIONLHN2026-04-01
04560333350358PROBEATHITACHI HIGH-TECH CORPORATIONLHN2026-04-01
04560333350365PROBEATHITACHI HIGH-TECH CORPORATIONLHN2026-04-01
04560333350372PROBEATHITACHI HIGH-TECH CORPORATIONLHN2026-04-01
04560333350389PROBEATHITACHI HIGH-TECH CORPORATIONLHN2026-04-01
04560333350396PROBEATHITACHI HIGH-TECH CORPORATIONLHN2026-04-01
04560333350419PROBEATHITACHI HIGH-TECH CORPORATIONLHN2026-04-01
04560333350426PROBEATHITACHI HIGH-TECH CORPORATIONLHN2026-04-01
04560333350433PROBEATHITACHI HIGH-TECH CORPORATIONLHN2026-04-01
04560333350440PROBEATHITACHI HIGH-TECH CORPORATIONLHN2026-04-01
04560333350457PROBEATHITACHI HIGH-TECH CORPORATIONLHN2026-04-01
04560333350464PROBEATHITACHI HIGH-TECH CORPORATIONLHN2026-04-01
03760290230170SDX SystemDYN'RLHN2026-02-20
03760290230187SDX SystemDYN'RLHN2026-02-20
04560333350280PROBEATHITACHI, LTD.LHN2026-01-20
00841962120456Alta for HexaPODQfixLHN2026-01-14
00841962120388Lumen AirShuttleQfixLHN2025-12-02