Device Type ID | 5279 |
Device Name | Source, Wire, Iridium, Radioactive |
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 | IWA |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |