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510(k) Data Aggregation
K Number
K152592Device Name
PROBEAT-V
Manufacturer
Hitachi, Ltd.,Health Care Company
Date Cleared
2015-11-02
(53 days)
Product Code
LHN
Regulation Number
892.5050Why did this record match?
Applicant Name (Manufacturer) :
Hitachi, Ltd.,Health Care Company
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The PROBEAT-V 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.
Device Description
The PROBEAT-V 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 site. The equipment to perform the above work is composed of two main components: (1) a beam delivery system whose primary responsibility is to ensure that the desired prescription parameters are properly delivered and (2) equipment necessary to generate the proton beam and direct it to the beam delivery system for patient treatment.
The beam delivery system is composed of the following components:
- Gantry Room
- Rotating Gantry
- Scanning Nozzle
- Patient Positioning System
- Cone Beam CT / X-ray Imaging System
- Fixed Beam Room
- Scanning Nozzle
- Patient Positioning System
- Cone Beam CT
The beam production system is composed of the following components:
- Accelerator system (LINAC, Synchrotron)
- Beam transport system (Low/High Energy Beam Transport systems)
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K Number
K151132Device Name
PROBEAT-V
Manufacturer
Hitachi, Ltd.,Health Care Company
Date Cleared
2015-06-01
(34 days)
Product Code
LHN
Regulation Number
892.5050Why did this record match?
Applicant Name (Manufacturer) :
Hitachi, Ltd.,Health Care Company
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The PROBEAT-V 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.
Device Description
The PROBEAT-V 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 site. The equipment to perform the above work is composed of two main components: (1) a beam delivery system properly delivered and (2) equipment necessary to generate the proton beam and direct it to the beam delivery system for patient treatment.
The beam delivery system is composed of the following components"
- o Gantry Room
- · Rotating Gantry
- . Scanning Nozzle
- . Patient Couch (or Patient Positioning System)
- . X-ray Imaging System
- o Fixed Beam Room
- Scanning Nozzle .
- . Patient Couch (or Patient Positioning System)
- . X-ray Imaging System
The beam production system is composed of the following components"
- Accelerator system (LINAC, Synchrotron) O
- Beam transport system (Low/High Energy Beam Transport systems) O
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