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510(k) Data Aggregation
K Number
K073059Device Name
PROBEAT WITH DISCRETE SPOT SCANNING SYSTEM
Manufacturer
HITACHI, LTD., POWER SYSTEMS GROUP
Date Cleared
2007-12-10
(41 days)
Product Code
LHN
Regulation Number
892.5050Why did this record match?
Applicant Name (Manufacturer) :
HITACHI, LTD., POWER SYSTEMS GROUP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Hitachi's 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.
Device Description
The PROBEAT with DSSS 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. The PBTS is designed to be safe and reliable. The equipment to perform the above work is comprised of two main components. One is a beam delivery system whose primary responsibility is to ensure that the desired prescription parameters are properly delivered. The other is the equipment necessary to generate the proton beam and direct it to the beam delivery system.
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K Number
K053280Device Name
PROBEAT
Manufacturer
HITACHI, LTD., POWER SYSTEMS GROUP
Date Cleared
2006-03-09
(106 days)
Product Code
LHN
Regulation Number
892.5050Why did this record match?
Applicant Name (Manufacturer) :
HITACHI, LTD., POWER SYSTEMS GROUP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Hitachi's PROBEAT 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 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 and dose distribution to the prescribed patient treatment site. The equipment is comprised of two main components. One is a beam delivery system whose primary responsibility is to ensure that the above listed prescription parameters are properly delivered. The other is the equipment necessary to generate the proton beam and direct it to the beam delivery system.
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