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510(k) Data Aggregation
K Number
K992414Device Name
PROTON BEAM THERAPY SYSTEM (PBTS)
Manufacturer
OPTIVUS TECHNOLOGY, INC.
Date Cleared
2000-07-21
(367 days)
Product Code
LHN
Regulation Number
892.5050Why did this record match?
Applicant Name (Manufacturer) :
OPTIVUS TECHNOLOGY, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Optivus Technology, Inc.'s Proton Beam Therapy System (PBTS) is an integrated facility designed to administer proton radiation treatments to patients through delivery of a predetermined radiation dose to a predetermined treatment target volume in a manner that protects people from unnecessary exposure to radiation and other hazards.
Device Description
The Optivus Proton Beam Therapy System (PBTS) is an integrated facility designed to deliver radiation treatment. Optivus' proposed facility is essentially the same as the facility that is currently operating at LLUMC. Both facilities consists of three major functional blocks; the accelerator, the beam transport system, and the treatment rooms. This complete, turnkey system consists of seven major subsystems:
- 70 - 250 MeV proton synchrotron;
- beam transport system;
- . one or more fixed beam delivery systems;
- . one or more isocentric gantries;
- patient positioning system;
- integrated facility control system; and .
- integrated facility safety system.
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