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The CRC 15Ultra multiple chamber dose calibrator, which includes optional beta counter and well counter, is intended to be used by qualified nuclear medicine technologists to measure a wide range radiopharmaceuticals, including high mergy beta and gamma emitters. It is also designed for use by trained medical physicists to measure the output of most radioactive brachytherapy sources, including HDR, LDR and IVBT sources. All brachytherapy sources must be measured in the appropriate source holder. The well counter is designed for measurement of low activity radioactive sources or solutions, including laboratory test applications. This device is used in numerous research applications for measurement of radioactive materials.

The Capintec CRC 15Ultra is a multiple detector system, which may include up to eight sealed pressurized re-entrant well chambers, plus a high energy beta counter, and a well counter. The CRC 15Ultra combines the features of several well established Capintec models: CRC 35R, CRC 15R, Beta Counter, and Caprac R Counter into one unit with flexible configurations which are field upgradeable. The 15Ultra incorporates enhanced electronic circuitry and faster microprocessor capabilities, which extends it capability to network eight ionization chambers, as did the CRC 35R. However, the CRC 15Ultra can also add the detector assembly from the Beta C Counter, or the detector assembly from the Caprac R Well Counter, to the same universal readout. The basic design concepts, functionality, calculations, algorithms, and response are the same.

This document is a 510(k) summary for the Capintec CRC 15Ultra. It does not contain information about the acceptance criteria and a study proving the device meets those criteria. The document is primarily focused on demonstrating substantial equivalence to predicate devices and lists applicable safety standards.

Therefore, I cannot fulfill your request for information on acceptance criteria and studies demonstrating device performance based on the provided text.

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