21 CFR 892.5710 — Block, Beam-Shaping, Radiation Therapy

Radiology (RA) · Subpart F—Therapeutic Devices · § 892.5710

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.

Classification Rationale

Class II.

Product Codes

Product CodeDevice NameClassDevicesAttributes
IXIBlock, Beam-Shaping, Radiation Therapy2513rd Party
Innolitics

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