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510(k) Data Aggregation
K Number
K983332Device Name
NORTHEAST PROTON THERAPY CENTER
Manufacturer
MASSACHUSETTS GENERAL HOSPITAL
Date Cleared
2001-07-20
(1032 days)
Product Code
LHN
Regulation Number
892.5050Why did this record match?
Applicant Name (Manufacturer) :
MASSACHUSETTS GENERAL HOSPITAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The NPTC is a facility designed to produce and deliver a proton beam of known energy, intensity and shape for treatment of a patient. It is indicated for use in the therapeutic application of a proton beam for the treatment of localized turnors or other diseases that are susceptible to treatment by radiation. The facility is designed so that it will: (1) create and direct (deliver) the proton beam appropriately to the patient treatment location: (2) produce a transverse and longitudinal dose distribution appropriate for the patient treatment; and (3) deliver the designated dose to the patient's treatment site.
Device Description
The equipment installed in the NPTC is comprised of the following two main components: (1) the beam delivery equipment and (2) the beam production equipment. The primary responsibility of the beam delivery equipment is to direct the proton beam to the patient's treatment site within the patient treatment location and to ensure that the patient critical functions are properly and safely carried out. The beam production equipment is necessary to produce the proton beam and direct it to the appropriate treatment room. In addition to the main components, the equipment in the NPTC also includes: (1) a Therapy Safety System ("TSS"); and (2) a computer-based Therapy Control System ("TCS").
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