Source, Isotope, Sealed, Gold, Titanium, Platinum

Device Code: 5286

Product Code(s): IWI

Device Classification Information

• Device Type ID: 5286
• Device Name: Source, Isotope, Sealed, Gold, Titanium, Platinum
• 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: IWI
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Eligible For Accredited Persons Expansion Pilot Program

Recognized Standards

Total Product Life Cycle

• Device Type ID: 5286
• Device: Source, Isotope, Sealed, Gold, Titanium, Platinum
• Product Code: IWI
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Radionuclide Brachytherapy Source.
• CFR Regulation Number: 892.5730 [🔎]

TPLC Last Update: 2019-04-02 21:03:40