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
• Submission Type: 510(k)
• Regulation Number: 892.5930
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No

Recognized Consensus Standard

• IEC 61674(1997)(2002) Amendment 1, Medical electrical equipment - Dosimeters with ionization chambers and/or semi-conductor detectors as used in X-ray diagnostic imaging

Third Party Review

• Eligible for Accredited Persons Program

Accredited Persons

• dekra certification b.v.
• intertek testing services
• regulatory technology services, llc
• tuv sud america inc.
• underwriters laboratories, inc.