| Device Type ID | 5379 |
| Device Name | Source, Brachytherapy, Radionuclide |
| Regulation Description | Radionuclide Brachytherapy Source. |
| Regulation Medical Specialty | Radiology |
| Review Panel | Radiology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(k) |
| CFR Regulation Number | 892.5730 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | KXK |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5379 |
| Device | Source, Brachytherapy, Radionuclide |
| Product Code | KXK |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Radionuclide Brachytherapy Source. |
| CFR Regulation Number | 892.5730 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ADVANCED NUCLIDE TECHNOLOGIES, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
C.R. BARD, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
CIVATECH ONCOLOGY, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ECKERT & ZIEGLER BEBIG GMBH | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ISOAID, L.L.C. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SALUTARIS MEDICAL DEVICES, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
SOURCE PRODUCTION & EQUIPMENT CO., INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
VARIAN | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
VARIAN MEDICAL SYSTEMS, INC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Inadequate Instructions For Healthcare Professional | 6 |
Sticking | 4 |
Positioning Failure | 1 |
Incorrect Measurement | 1 |
Use Of Device Problem | 1 |
Activation, Positioning Or Separation Problem | 1 |
No Apparent Adverse Event | 1 |
Adverse Event Without Identified Device Or Use Problem | 1 |
Device Inoperable | 1 |
Device Operates Differently Than Expected | 1 |
| Total Device Problems | 18 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Bard Brachytherapy, Inc. | II | Apr-27-2018 |
| 2 | C.R. Bard, Inc. | II | Dec-20-2017 |
| 3 | Source Production & Equipment Inc | II | Jun-25-2015 |