21 CFR 892.1360 — Calibrator, Dose, Radionuclide

Radiology (RA) · Subpart B—Diagnostic Devices · § 892.1360

Identification

A radionuclide dose calibrator is a radiation detection device intended to assay radionuclides before their administration to patients.

Classification Rationale

Class II.

Product Codes

Product CodeDevice NameClassDevicesAttributes
KPTCalibrator, Dose, Radionuclide2323rd Party
Innolitics

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