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K Number
K071396
Device Name
CRC 25 SERIES (CRC 25R, CRC 25PET, CRC 25W) DOSE CALIBRATORS
Manufacturer
CAPINTEC, INC.
Date Cleared
2007-06-28

(38 days)

Product Code
KPT
Regulation Number
892.1360
Type
Special
Panel
RA
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The CRC 25R dose calibrator, which includes optional well counter (CRC 25W) or reduced pressure chamber (CRC 25PET), is intended to be used by qualified nuclear medicine technologists to measure a wide range radiopharmaceuticals, including high energy 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.

Device Description

The Capintec CRC 25 series is a reduced feature version of the CRC 15Ultra. The CRC 25 series uses the same basic hardware, and same detectors as the CRC 15 Ultra, but does not provide the ability to use multiple chambers, nor does the CRC 25 support the addition of a beta counter. The basic detection, measurement process, design concepts, functionality, calculations, algorithms, and response remain the same as the predicate device.

AI/ML Overview

This document is a 510(k) premarket notification for the Capintec CRC 25 series radionuclide dose calibrator. It details the device's substantial equivalence to a predicate device (CRC 15Ultra) and its compliance with safety standards, but it does not contain any information regarding acceptance criteria or the results of a study designed to prove the device meets those criteria.

Therefore, I cannot provide the requested information. The document focuses on regulatory approval and substantial equivalence based on existing hardware and concepts, rather than presenting a performance study with detailed acceptance criteria and results.

§ 892.1360 Radionuclide dose calibrator.

(a)
Identification. A radionuclide dose calibrator is a radiation detection device intended to assay radionuclides before their administration to patients.(b)
Classification. Class II.