Iridium Seeds
by Radiation Safety & Nuclear Products, Inc.
510(k) K850382
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK850382 | Date15 Aug 1985 | StatusActive |
Recalls
No FDA recalls found in the data synced 5 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- IWA
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.5730
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
Iridium Seeds are radioactive wire sources classified under the FDA’s product code IWA, designed for use in brachytherapy procedures. These devices emit radiation to treat localized cancers, particularly in radiology applications such as prostate, cervical, or breast cancer. Manufactured as permanent implants, they deliver targeted radiation therapy directly to tumors while minimizing exposure to surrounding healthy tissue. The device falls under the FDA’s Class II regulatory category, requiring special controls to ensure safety and efficacy in clinical settings.
Iridium Seeds are supplied sterile and intended for single-use implantation by qualified radiation oncologists or interventional radiologists. Each seed is pre-measured and calibrated to deliver precise radiation doses, with sizes and activity levels standardized for specific treatment protocols. They are packaged in radiation-shielded containers to ensure safe handling and transport, adhering to FDA’s 510(k) clearance (K850382) under the Radiology Advisory Committee. Storage requires compliance with nuclear safety regulations, including proper shielding and inventory tracking, to mitigate radiation risks. No MRI compatibility data is provided, and reuse is contraindicated due to radiation degradation.
Other devices from Radiation Safety & Nuclear Products, Inc.
Questions
AI-generated answers, 1 Oct 2026
What are Iridium seeds used for in medical treatment?
Iridium seeds are designed for brachytherapy procedures, a form of radiation therapy where they are permanently implanted to deliver targeted radiation directly to tumors. This approach is particularly effective for treating localized cancers such as prostate, cervical, or breast cancer, as it minimizes exposure to surrounding healthy tissue while ensuring precise dose delivery.
How are Iridium seeds supplied and prepared for use?
Iridium seeds are supplied sterile and pre-packaged in radiation-shielded containers to ensure safe handling and transport. Each seed is pre-measured and calibrated to match specific treatment protocols, allowing radiation oncologists or interventional radiologists to implant them directly into the tumor site during surgery. The shielding prevents accidental radiation exposure during preparation and use.
Are Iridium seeds reusable, and if not, why?
No, Iridium seeds are intended for single-use only. Reuse is contraindicated because prolonged exposure to radiation degrades the integrity and efficacy of the seeds, posing risks to both patients and healthcare providers. Their design ensures a one-time, controlled release of radiation for optimal therapeutic outcomes.
What storage requirements apply to Iridium seeds?
Iridium seeds must be stored in compliance with nuclear safety regulations, including proper shielding to prevent radiation leakage and inventory tracking to monitor usage. Facilities handling these devices should follow strict protocols to mitigate risks, as they emit ionizing radiation that requires controlled environments to ensure safety for staff and patients.
What regulatory approvals do Iridium seeds hold?
Iridium seeds are cleared by the FDA under the 510(k) pathway (K850382) as substantially equivalent to predicate devices, falling under the Radiology Advisory Committee’s review. They are classified as Class II devices, requiring special controls to ensure safety and efficacy in clinical brachytherapy applications.