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Radiation Therapy Marking Device

Product code

QRN

Device name

Radiation Therapy Marking Device

Device class

Class 2

21 CFR

21 CFR 892.5785

Medical specialty

Radiology

Marketing pathway

510(K)

510(k) clearances (all years, FDA)

2 (all years; only the last 3 years are listed here)

FDA classification definition

A radiation therapy marking device is a powered device that transdermally delivers a permanent or temporary colorant to the skin for the purpose of placing marks to guide radiation therapy. This classification does not include devices with reusable or reprocessed needles or devices intended for diagnostic, therapeutic, or aesthetic use or to deliver other products for these uses.

Definition text from the FDA device classification database (U.S. federal government work, public domain).