ONL · Class II · 21 CFR 892.5730

FDA Product Code ONL: Conformal Brachytherapy Source

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.

1
Total
1
Cleared
107d
Avg days
2009
Since

FDA 510(k) Cleared Conformal Brachytherapy Source Devices (Product Code ONL)

1 devices
1–1 of 1
No devices found for this product code.

About Product Code ONL - Regulatory Context