System, Applicator, Radionuclide, Manual

Device Code: 5287

Product Code(s): IWJ

Device Classification Information

• Device Type ID: 5287
• Device Name: System, Applicator, Radionuclide, Manual
• Regulation Description: Manual Radionuclide Applicator System.
• Regulation Medical Specialty: Radiology
• Review Panel: Radiology
• Premarket Review: Office Of In Vitro Diagnostics And Radiological Health (OIR)
• Submission Type: 510(K) Exempt
• CFR Regulation Number: 892.5650 [🔎]
• FDA Device Classification: Class 1 Medical Device
• Product Code: IWJ
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

Recognized Standards

• 12-259 IEC 61674 Edition 2.0 2012-11
  Medical Electrical Equipment -- Dosimeters With Ionization Chambers And/or Semiconductor Detectors As Used In X-ray Diagnostic Imaging

Total Product Life Cycle

• Device Type ID: 5287
• Device: System, Applicator, Radionuclide, Manual
• Product Code: IWJ
• FDA Device Classification: Class 1 Medical Device
• Regulation Description: Manual Radionuclide Applicator System.
• CFR Regulation Number: 892.5650 [🔎]

Device Problems
Device Inoperable	2
Bent	1
Manufacturing, Packaging Or Shipping Problem	1
Failure To Discharge	1
Total Device Problems	5

Recalls
Manufacturer		Recall Class	Date Posted
1	Riverpoint Medical, LLC	III	Jan-28-2019
2	Theragenics Corporation	II	Dec-19-2018

TPLC Last Update: 2019-04-02 21:03:42