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
- 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 ME | July 2, 1998 |
| K940632 | medi-physics inc. dba nycomed amersham imaging | I-125 RAPID STRAND | September 2, 1994 |
| K912170 | best industries | RADIOACTIVE IODINE-125 SOURCES | August 9, 1991 |
| K882449 | cis-us | CESIUM 137 SOURCE, MODEL CSM-40 | April 14, 1989 |
| K874787 | theragenics | MODIFIED PALLADIUM SEED MODEL 100 | December 22, 1987 |
| K852542 | nuclear medicine | PALLADIUM SEED MODEL 100 | January 14, 1986 |