21 CFR 892.5700 — System, Applicator, Radionuclide, Remote-Controlled

Radiology (RA) · Subpart F—Therapeutic Devices · § 892.5700

Identification

A remote controlled radionuclide applicator system is an electromechanical or pneumatic device intended to enable an operator to apply, by remote control, a radionuclide source into the body or to the surface of the body for radiation therapy. This generic type of device may include patient and equipment supports, component parts, treatment planning computer programs, and accessories.

Classification Rationale

Class II.

Product Codes

Product CodeDevice NameClassDevicesAttributes
JAQSystem, Applicator, Radionuclide, Remote-Controlled2206
Innolitics

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