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Conformal Brachytherapy Source

FDA product code ONL · 1 cleared devices

Class 2 Radiology
Regulation
21 CFR 892.5730
Review panel
RA
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2009-05-27 – 2009-05-27

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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