I-125 SEEDS, CODE: 6711
Device Facts
| Record ID | K914281 |
|---|---|
| Device Name | I-125 SEEDS, CODE: 6711 |
| Applicant | Medi-Physics Inc. Dba Nycomed Amersham Imaging |
| Product Code | KXK · Radiology |
| Decision Date | Nov 22, 1991 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.5730 |
| Device Class | Class 2 |
Regulatory Classification
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.
Special Controls
*Classification.* Class II (special controls). A prostate seeding kit intended for use with a radionuclide brachytherapy source only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
