ONL

Conformal Brachytherapy Source

Product code

ONL

Device name

Conformal Brachytherapy Source

Device class

Class 2

21 CFR

21 CFR 892.5730

Medical specialty

Radiology

Marketing pathway

510(K)

510(k) clearances (all years, FDA)

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

FDA classification definition

The intended use of the device is for the treatment of cancer by tempeorary intraoperative or surface irradiation. The device contains radioactive material with activity up to 200 mci and is indicated for treatment of temporary intraoperative, interstitial, intracavitary or surface application to treat selected localized tumors. This brachytherapy source may be used concurrently with or following treatment with other interventions, such as external beam therapy. Chordomas, chondrosarcomas, soft tissue sarcomas, skin cancers and other accessible tumors could be commonly treated by the device.

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