U.S. FDA Medical Device Nuclear Flood Source Phantom Requirements
FDA Medical Device Definition: A nuclear flood source phantom is a device that consists of a radiolucent container filled with a uniformly distributed solution of a desired radionuclide. It is intended to calibrate a medical gamma camera-collimator system for uniformity of response.
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U.S. FDA Regulations:
U.S. FDA 510(k) Regulation: 21 C.F.R. section 814.9.
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