FDA.reportPublic FDA data

PROBEAT

Primary DI
04560333350228
Brand
PROBEAT
Company
HITACHI, LTD.
Model
Real Time Image Gating System for Proton Beam Ther
Device description
The Real Time Image Gating System for Proton Beam Therapy Systems is intended for use with compatible Hitachi proton beam therapy systems and is designed to generate gating signals to deliver a proton beam when the position of a fiducial marker, which is implanted near a tumor and tracked by use of X-ray fluoroscopy, is within a given tolerance from its planned position.
Published
2023-12-20
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
K171049000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K171049000Real Time Image Gating System for Proton Beam Therapy SystemsHitachi, Ltd. Healthcare2017-12-26LHN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04560333350228PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04560333350228045603333502284560333350228

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
739444076
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04562122958639HITACHIDAS-RS12019-07-01
04560333350280PROBEATSmall Field Applicator for PROBEAT-V2026-01-20
04560333350204PROBEATPROBEAT-FR2024-01-19
04560333350211PROBEATMini Ridge Filter and auxiliary functions for PROB2023-12-20
04560333350198PROBEATSmall Field Applicator for PROBEAT-V2023-10-02
04560333350006PROBEATPROBEAT-CR2019-09-24
04562122951555HITACHIMP-2445-SET2018-09-24
04562122951562HITACHIMP-24502018-09-23
04562122951616HITACHIMP-2748-SET2018-09-24
04562122951630HITACHIMP-2445-G142018-09-24
04562122951647HITACHIMP-2445-G162018-09-24
04562122951654HITACHIMP-2445-G172018-09-24
04562122951661HITACHIMP-2445-G182018-09-24
04562122951678HITACHIMP-2445-G222018-09-24
04562122951685HITACHIMP-2452-G162018-09-24
04562122951692HITACHIMP-2452-G182018-09-24
04562122951708HITACHIMP-2748-G162018-09-24
04562122951715HITACHIMP-2748-G172018-09-24
04562122951722HITACHIMP-2748-G182018-09-24
04562122956260HITACHIMP-24482018-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850065937007eMotusEMPNIA INC.LHN2026-09-21
00850065937014eMotusEMPNIA INC.LHN2026-09-21
00850065937021eMotusEMPNIA INC.LHN2026-09-21
00850065937038eMotusEMPNIA INC.LHN2026-09-21
00850065937045eMotusEMPNIA INC.LHN2026-09-21
00850065937052eMotusEMPNIA INC.LHN2026-09-21
00850065937069eMotusEMPNIA INC.LHN2026-09-21
00850065937076eMotusEMPNIA INC.LHN2026-09-21
00850065937083eMotusEMPNIA INC.LHN2026-09-21
00850065937090eMotusEMPNIA INC.LHN2026-09-21
00850065937106eMotusEMPNIA INC.LHN2026-09-21
00850065937113eMotusEMPNIA INC.LHN2026-09-21
00850065937120eMotusEMPNIA INC.LHN2026-09-21
00850065937137eMotusEMPNIA INC.LHN2026-09-21
00850065937144eMotusEMPNIA INC.LHN2026-09-21
00850065937151eMotusEMPNIA INC.LHN2026-09-21
00850065937168eMotusEMPNIA INC.LHN2026-09-21
00850065937175eMotusEMPNIA INC.LHN2026-09-21
00850065937182eMotusEMPNIA INC.LHN2026-09-21
00850065937199eMotusEMPNIA INC.LHN2026-09-21
00850065937205eMotusEMPNIA INC.LHN2026-09-21
00850065937212eMotusEMPNIA INC.LHN2026-09-21
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