ONL

Conformal Brachytherapy Source

产品代码

ONL

器械名称

Conformal Brachytherapy Source

管理类别

第 2 类（Class II）

21 CFR 条款

21 CFR 892.5730

FDA 专业组

Radiology

上市路径

需提交 510(k) 上市前通告

该代码近三年的 510(k)

1 件

FDA 分类定义

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.

定义原文来自 FDA 器械分类库，属美国联邦政府作品（公有领域）。