K Number
K002833Device Name
MODIFICATION TO STANDARD IMAGING PT 1000 ION CHAMBER
Manufacturer
Date Cleared
2000-09-28
(16 days)
Product Code
Regulation Number
892.1360AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
More Information
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§ 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.
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