Product Classification

• Device: assembly, tube housing, x-ray, therapeutic
• Regulation Description: Therapeutic x-ray tube housing assembly.
• Regulation Medical Specialty: Radiology
• Review Panel: Radiology
• Product Code: ITZ
• Premarket Review: Office of Radiological Health (OHT8); Radiological Imaging and Radiation Therapy Devices (DHT8C)
• Submission Type: 510(k)
• Regulation Number: 892.5930
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Eligible
• Implanted Device?: No
• Life-Sustain/Support Device?: No

Recognized Consensus Standard

• 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

Third Party Review

• Eligible for 510(k) Third Party Review Program

Accredited Persons

• global quality and regulatory services
• regulatory technology services, llc
• third party review group, llc