Seed, Isotope, Gold, Titanium, Platinum

Device Code: 5284

Product Code(s): IWG

Device Classification Information

Device Type ID5284
Device NameSeed, Isotope, Gold, Titanium, Platinum
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 CodeIWG
GMP ExemptNo
Summary MREligible
Implanted DeviceYes
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID5284
DeviceSeed, Isotope, Gold, Titanium, Platinum
Product CodeIWG
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionRadionuclide Brachytherapy Source.
CFR Regulation Number892.5730 [🔎]
TPLC Last Update: 2019-04-02 21:03:38

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