Source, Isotope, Sealed, Gold, Titanium, Platinum
FDA product code IWI · Class II (moderate risk) · 21 CFR 892.5730 · Radiology
6510(k) clearances
0PMA approvals
0recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K973363 | North American SCIENTIFIC(NASI)PD-103 Radionuclide Brachytherapy Source-Model MED3633IWI · Traditional | Ml Strategies, Inc. | 07/02/1998SE |
| K940632 | I-125 Rapid StrandIWI · Traditional | Medi-Physics Inc. Dba Nycomed Amersham Imaging | 09/02/1994SE |
| K912170 | Radioactive IODINE-125 SourcesIWI · Traditional | Best Industries | 08/09/1991SE |
| K882449 | Cesium 137 Source, Model CSM-40IWI · Traditional | Cis-Us, Inc. | 04/14/1989SE |
| K874787 | Modified Palladium Seed Model 100IWI · Traditional | Theragenics Corp. | 12/22/1987SE |
| K852542 | Palladium Seed Model 100IWI · Traditional | Nuclear Medicine, Inc. | 01/14/1986SE |