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K Number
K001163

Validate with FDA (Live)

Device Name
DMLC IV-ERGO
Manufacturer
3D LINE USA, INC.
Date Cleared
2000-10-23

(196 days)

Product Code
IXI
Regulation Number
892.5710
Type
Traditional
Panel
Radiology
Age Range
N/A
Reference & Predicate Devices
N/A
Predicate For
K013535,K032762,K040474,K080601,K111676
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

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§ 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.