Product code IWI
- Device name
- Source, Isotope, Sealed, Gold, Titanium, Platinum
- Medical specialty
- Radiology
- Device class
- 2
- Regulation number
- 892.5730
- Review panel
- RA
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K973363 | NORTH AMERICAN SCIENTIFIC(NASI)PD-103 RADIONUCLIDE BRACHYTHERAPY SOURCE-MODEL MED3633 | Ml Strategies, Inc. | 1998-07-02 |
| K940632 | I-125 RAPID STRAND | Medi-Physics Inc. Dba Nycomed Amersham Imaging | 1994-09-02 |
| K912170 | RADIOACTIVE IODINE-125 SOURCES | Best Industries | 1991-08-09 |
| K882449 | CESIUM 137 SOURCE, MODEL CSM-40 | Cis-Us, Inc. | 1989-04-14 |
| K874787 | MODIFIED PALLADIUM SEED MODEL 100 | Theragenics Corp. | 1987-12-22 |
| K852542 | PALLADIUM SEED MODEL 100 | Nuclear Medicine, Inc. | 1986-01-14 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00841365106965 | Best Medical International | BEST MEDICAL INTERNATIONAL, INC. | 2015-09-23 |
| 00841365106972 | Best Medical International | BEST MEDICAL INTERNATIONAL, INC. | 2015-09-23 |
| 00841365106989 | Best Medical International | BEST MEDICAL INTERNATIONAL, INC. | 2015-09-23 |
| 00841365106996 | Best Medical International | BEST MEDICAL INTERNATIONAL, INC. | 2015-09-23 |
| 00841365107009 | Best Medical International | BEST MEDICAL INTERNATIONAL, INC. | 2015-09-23 |
| 00841365107016 | Best Medical International | BEST MEDICAL INTERNATIONAL, INC. | 2015-09-23 |
| 00841365107023 | Best Medical International | BEST MEDICAL INTERNATIONAL, INC. | 2015-09-23 |
| 00841365107030 | Best Medical International | BEST MEDICAL INTERNATIONAL, INC. | 2015-09-23 |
| 00841365107047 | Best Medical International | BEST MEDICAL INTERNATIONAL, INC. | 2015-09-23 |
| 00841365107054 | Best Medical International | BEST MEDICAL INTERNATIONAL, INC. | 2015-09-23 |
| 00841365107061 | Best Medical International | BEST MEDICAL INTERNATIONAL, INC. | 2015-09-23 |
| 00841365107078 | Best Medical International | BEST MEDICAL INTERNATIONAL, INC. | 2015-09-23 |
| 00841365107085 | Best Medical International | BEST MEDICAL INTERNATIONAL, INC. | 2015-09-23 |
| 00841365112539 | Best Medical International | BEST MEDICAL INTERNATIONAL, INC. | 2015-09-23 |
| 00841365112560 | Best Medical International | BEST MEDICAL INTERNATIONAL, INC. | 2015-09-23 |