ONL

1 FDA 510(k) clearances · Product code

FDA profile

Official device name

Conformal Brachytherapy Source

Device class

Class II (moderate risk)

Regulation

21 CFR 892.5730

Medical specialty

Radiology

FDA 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.

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