21 CFR 892.5650 — System, Applicator, Radionuclide, Manual

Radiology (RA) · Subpart F—Therapeutic Devices · § 892.5650

Identification

A manual radionuclide applicator system is a manually operated device intended to apply 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 I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 892.9.

Product Codes

Product CodeDevice NameClassDevicesAttributes
IWJSystem, Applicator, Radionuclide, Manual136
Innolitics

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