IWI — Source, Isotope, Sealed, Gold, Titanium, Platinum Class II
FDA product code IWI covers "Source, Isotope, Sealed, Gold, Titanium, Platinum", a Class II medical device regulated under 21 CFR 892.5730. Submissions are reviewed by the Radiology panel. At least 6 recent 510(k) clearances have been granted under this product code.
Classification details
- Product Code
- IWI
- Device Class
- Class II
- Regulation Number
- 892.5730
- Submission Type
- 510(k)
- Review Panel
- RA
- Medical Specialty
- Radiology
- Implant
- No
Recent 510(k) clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K973363 | Ml Strategies | NORTH AMERICAN SCIENTIFIC(NASI)PD-103 RADIONUCLIDE BRACHYTHERAPY SOURCE-MODEL… | Jul 2, 1998 |
| K940632 | Medi-Physics Inc. Dba Nycomed Amersham Imaging | I-125 RAPID STRAND | Sep 2, 1994 |
| K912170 | Best Industries | RADIOACTIVE IODINE-125 SOURCES | Aug 9, 1991 |
| K882449 | Cis-Us | CESIUM 137 SOURCE, MODEL CSM-40 | Apr 14, 1989 |
| K874787 | Theragenics | MODIFIED PALLADIUM SEED MODEL 100 | Dec 22, 1987 |
| K852542 | Nuclear Medicine | PALLADIUM SEED MODEL 100 | Jan 14, 1986 |