inforMED
ONLClass II

Conformal Brachytherapy Source

Radiology · 21 CFR 892.5730

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.

MDR events1All time
Recalls0All time
Registered firms0Currently listed
510(k) clearances1All time

Event type breakdown

Injury1

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Recalls

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No recalls on file for this product code.

Registered firms

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No registered firms found for this product code.