DMLC IV-ERGO

K001163 · 3D Line USA, Inc. · IXI · Oct 23, 2000 · Radiology

Device Facts

Record IDK001163
Device NameDMLC IV-ERGO
Applicant3D Line USA, Inc.
Product CodeIXI · Radiology
Decision DateOct 23, 2000
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 892.5710
Device ClassClass 2

Regulatory Classification

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.

Innolitics

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