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OmniDos is used to accurately analyse and handle the measured dose distribution in quality assurance purposes, for calibration of radiation devices, as input data to Treatment Planning Systems, for acceptance testing, beam tuning and in research.

The Scanditronix & Wellhöfer OmniDos is a General Dosimetry System similar to Wellhöfer Dosimetrie: WP700, FDA K945321/S1, 1995, 29th of March. Scanditronix Medical: RFA-300, FDA K934303/S1, 510(k) Aug 1994, Scanditronix Medical: RFA-300, LDA Utility, FDA K961400: Jan. 1997. OmniDos and the marketed predicated products are radiotherapy quality assurance measuring devices designed to measure dose distribution. Using appropriate detectors and servo/scanners, the dose distribution can be accurately measured to provide acceptance testing, beam tuning, routine beam verifications, isodose tracking and linear scans. These devices are designed to function in conjunction with a PC, which controls the relative position of the detectors while measuring and storing dose information of the radiotherapy beam. Each device is designed to provide two or more channels from electrometers which have their results converted into digital information for storage, display, or transfer to other systems for radiation therapy treatment planning using data formats suitable for the other system. Depending on configuration the devices offer several options for use of the detector system, including film scanning, TMR measurements, and other options.

The DPD-12PC Direct Patient Dosemeter is used - to monitor radiation dosage to a patient during radiotherapy procedure - for quality control measurements of therapeutic radiation devices

The Scanditronix Medical DPD-12PC, Direct Patient Dosemeter is a device modification of DPD-3, Direct Patient Dosemeter, FDA K9420921, 510(k) July 1994 used for In Vivo Dosimetry in radiation therapy. It consists of a 12 channel electrometer, display unit (personal computer) semiconductor detectors, detector support, extension cable, communication cable.

The Scanditronix Medical RFA-300, LDA Utility is used to more effectively perform radiation therapy beam measurements including acceptance testing, trimming information, routine beam checks and quality assurance measurements and on-line data analyses using personal computer (PC) monitor. These uses are similar to those of the predicate identified in section (3) of this Summary.

The Scanditronix Medical RFA-300, LDA Utility is an extension to the RFA-300 system used to measure radiation therapy beam intensity. For use, a complete RFA-300 system is needed extended with the following equipment: 1. Multichannel electrometers emX which provides 12 independent electrometer channels each or a DPD-510 which provides 10 independent electrometer channels. 2. Linear Detector Array LDA-11 (11 detectors) or LDA-25 (25 detectors). 3. PC-based software providing control, display, calibration and save functions.