(234 days)
The Mark VI Dose Calibrator is designed to measure the amount of radioactive material in vials, syringes and capsules. It is used to measure the amount of activity used to prepare radiopharmaceutical kits, measure the activity in syringes of radiopharmaceuticals prior to injection and to quantify the activity remaining in the syringe following injection. It is indicated for use in the preparation of radiopharmaceuticals and verification of the activity prior to patient administration.
The Mark VI Dose Calibrator is designed to measure the amount of radioactive material in vials, syringes and capsules. Data related to the factory calibration is stored in the chamber. This standardizes the response of each ion chamber, allowing each chamber to report the same amount of electric current for the same radiation source. The isotopic calibration factors are stored in the control/readout unit. The ion chamber current is processed using the isotopic calibration factors stored in the control unit in order to determine the amount of radioactive material present.
I am sorry, but the provided text does not contain the information required to answer your request. The document is a 510(k) clearance letter from the FDA for a radionuclide dose calibrator. It confirms that the device is substantially equivalent to a legally marketed predicate device but does not detail acceptance criteria, study methodologies, sample sizes, expert qualifications, or ground truth establishment.
§ 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.