IWG · Seed, Isotope, Gold, Titanium, Platinum
Radiology · 21 CFR 892.5730 · Class 2
Overview
| Product Code | IWG |
|---|---|
| Device Name | Seed, Isotope, Gold, Titanium, Platinum |
| Regulation | 21 CFR 892.5730 |
| Device Class | Class 2 |
| Review Panel | Radiology |
| Implant | Yes |
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.
Classification Rationale
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.
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.
Cleared Devices (3)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K081066 | BRACHYTHERAPY SOURCE DEVICE, MODEL 9011 | Medi-Physics, Inc., Dba GE Healthcare | May 5, 2008 | SESE |
| K982421 | IMAGYN 125 I SEED, MODEL IS 125 | International Isotopes, Inc. | Jul 31, 1998 | SESE |
| K834027 | GOLD SEADS | Radiation Safety & Nuclear Products, Inc. | Dec 27, 1983 | SESE |
Top Applicants
- Radiation Safety & Nuclear Products, Inc. — 1 clearance
- Medi-Physics, Inc., Dba GE Healthcare — 1 clearance
- International Isotopes, Inc. — 1 clearance
