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510(k) Data Aggregation
(87 days)
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.
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.
This document describes a medical device, the RPS-50 Beam Scanner, which is a beam scanner for clinical linear accelerators. However, the provided text does not contain any information regarding acceptance criteria, device performance, study details, sample sizes, ground truth establishment, or expert involvement.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, as this information is absent in the input.
The input primarily provides:
- Trade Name, Common Name, Classification, Class, and Predicate Device.
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- Its intended use.
- A brief statement on its technological characteristics in comparison to the predicate.
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