K Number
K111759Device Name
.DECIMAL ELECTRON APERTUREManufacturer
Date Cleared
2011-09-09
(79 days)
Product Code
Regulation Number
892.5710Type
TraditionalPanel
RAReference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
§ 892.5710 Radiation therapy beam-shaping block.
(a)
Identification. A radiation therapy beam-shaping block is a device made of a highly attenuating material (such as lead) intended for medical purposes to modify the shape of a beam from a radiation therapy source.(b)
Classification. Class II.