Source, Wire, Iridium, Radioactive

Device Code: 5279

Product Code(s): IWA

Device Classification Information

Device Type ID5279
Device NameSource, Wire, Iridium, Radioactive
Regulation DescriptionRadionuclide Brachytherapy Source.
Regulation Medical SpecialtyRadiology
Review PanelRadiology
Premarket Review Office Of In Vitro Diagnostics And Radiological Health (OIR)
Submission Type510(k)
CFR Regulation Number892.5730 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeIWA
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Eligible For Accredited Persons Expansion Pilot Program

Recognized Standards

Total Product Life Cycle

Device Type ID5279
DeviceSource, Wire, Iridium, Radioactive
Product CodeIWA
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionRadionuclide Brachytherapy Source.
CFR Regulation Number892.5730 [🔎]
TPLC Last Update: 2019-04-02 21:03:33

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