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K Number
K011493
Device Name
MENTOR ISOLOADER AUTOMATIC NEEDLE LOADING SYSTEM AND PHYSICS WORKSTATION FOR BRACHYTHERAPY
Manufacturer
MENTOR CORP.
Date Cleared
2002-10-01

(504 days)

Product Code
KPT
Regulation Number
892.1360
Type
Traditional
Panel
RA
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

§ 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.