Seed, Isotope, Gold, Titanium, Platinum
A gold, titanium, or platinum isotope seed is a small encapsulated radioactive source implanted permanently or temporarily into tissue for brachytherapy treatment of localized tumors such as prostate cancer, delivering targeted radiation to the tumor site. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) premarket notification. The product code is IWG, regulated under 21 CFR 892.5730, within the Radiology medical specialty. This device is classified as an implant.
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Basic Information
- Product Code
- IWG
- Device Class
- FDA class 2
- Regulation Number
- 892.5730
- Medical Specialty
- Radiology
- Review Panel
- RA
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K081066 | BRACHYTHERAPY SOURCE DEVICE, MODEL 9011 | May 05, 2008 | Substantially Equivalent | Medi-Physics, Inc., Dba GE Healthcare |
| K982421 | IMAGYN 125 I SEED, MODEL IS 125 | Jul 31, 1998 | Substantially Equivalent | International Isotopes, Inc. |
| K834027 | GOLD SEADS | Dec 27, 1983 | Substantially Equivalent | Radiation Safety & Nuclear Products, Inc. |
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.