K Number
K002833
Device Name
MODIFICATION TO STANDARD IMAGING PT 1000 ION CHAMBER
Date Cleared
2000-09-28

(16 days)

Product Code
Regulation Number
892.1360
AI/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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