Vivos Inc (RDGL)

[kayak_wench]

If you look up isorays 510(k) approval from 2003 it references the regulation under which it was given 510(k) status. It is below. I don't think admd biodegradable seeds will meet this criteria any more than radiogel. I think it too will require de nova or PMA

"(a)Identification. A radionuclide brachytherapy source is a device that consists of a radionuclide which may be enclosed in a sealed container made of gold, titanium, stainless steel, or platinum and intended for medical purposes to be placed onto a body surface or into a body cavity or tissue as a source of nuclear radiation for therapy."