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510(k) Data Aggregation
K Number
K962080Device Name
RPS-50 BEAM SCANNER
Manufacturer
Date Cleared
1996-08-23
(87 days)
Product Code
Regulation Number
892.5050Why did this record match?
Applicant Name (Manufacturer) :
SOFIELD SCIENCE SERVICES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The RPS-50 is intended to be used as an accessory to a linear accelerator under the direct control of a qualified individual (usually a therapeutic radiation physicist.) The scanner may be used for acceptance testing of new accelerators, quality control of existing accelerators, or for the collection of data necessary for the operation of a computerized treatment planning system.
Device Description
The RPS-50 scanner consists of a water tank, linear scanning guides, electronic control of movement, chamber bias, and system gain control. A software program controls all movements and necessary electronic signals. The scanner moves a radiation detector through a field of high radiation and presents the collected data as a plot on a computer screen, as a table of data or on a floppy disk suitable for use in a treatment planning system.
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