Assembly, Tube Housing, X-ray, Therapeutic

Device Code: 5278

Product Code(s): ITZ

Device Classification Information

• Device Type ID: 5278
• Device Name: Assembly, Tube Housing, X-ray, Therapeutic
• Regulation Description: Therapeutic X-ray Tube Housing Assembly.
• 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: 892.5930 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: ITZ
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Eligible For Accredited Persons Program

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: 5278
• Device: Assembly, Tube Housing, X-ray, Therapeutic
• Product Code: ITZ
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Therapeutic X-ray Tube Housing Assembly.
• CFR Regulation Number: 892.5930 [🔎]

TPLC Last Update: 2019-04-02 21:03:32