Generator, High Voltage, X-ray, Therapeutic

Device Code: 5375

Product Code(s): KPZ

Device Classification Information

• Device Type ID: 5375
• Device Name: Generator, High Voltage, X-ray, Therapeutic
• Regulation Description: X-ray Radiation Therapy System.
• 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: 892.5900 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: KPZ
• 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

• 12-217 IEC 62083 Edition 2.0 2009-09
  Medical Electrical Equipment - Requirements For The Safety Of Radiotherapy Treatment Planning Systems
• 12-304 IEC 60731 Edition 3.1 2016-04
  Consolidated Version Medical Electrical Equipment - Dosimeters With Ionization Chambers As Used In Radiotherapy

Total Product Life Cycle

• Device Type ID: 5375
• Device: Generator, High Voltage, X-ray, Therapeutic
• Product Code: KPZ
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: X-ray Radiation Therapy System.
• CFR Regulation Number: 892.5900 [🔎]

Device Problems
Thermal Decomposition Of Device	1
Total Device Problems	1

TPLC Last Update: 2019-04-02 21:05:08