Source, Isotope, Sealed, Gold, Titanium, Platinum
A sealed gold, titanium, or platinum isotope source is a brachytherapy source in which a radioactive material is permanently sealed within a metal capsule, used for interstitial or intracavitary radiation therapy to deliver localized doses to target tissue. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) premarket notification. The product code is IWI, regulated under 21 CFR 892.5730, within the Radiology medical specialty. This device is eligible for third party 510(k) review.
Basic Information
- Product Code
- IWI
- 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 6 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K973363 | NORTH AMERICAN SCIENTIFIC(NASI)PD-103 RADIONUCLIDE BRACHYTHERAPY SOURCE-MODEL MED3633 | Jul 02, 1998 | Substantially Equivalent | ML STRATEGIES, INC. |
| K940632 | I-125 RAPID STRAND | Sep 02, 1994 | Substantially Equivalent | MEDI-PHYSICS INC. DBA NYCOMED AMERSHAM IMAGING |
| K912170 | RADIOACTIVE IODINE-125 SOURCES | Aug 09, 1991 | Substantially Equivalent | BEST INDUSTRIES |
| K882449 | CESIUM 137 SOURCE, MODEL CSM-40 | Apr 14, 1989 | Substantially Equivalent | CIS-US, INC. |
| K874787 | MODIFIED PALLADIUM SEED MODEL 100 | Dec 22, 1987 | Substantially Equivalent | THERAGENICS CORP. |
| K852542 | PALLADIUM SEED MODEL 100 | Jan 14, 1986 | Substantially Equivalent | NUCLEAR MEDICINE, 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.