• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Product Classification

  • Print
  • Share
  • E-mail
New Search Back to Search Results
Device dosimeter, ionizing radiation, implanted
Regulation Description Medical charged-particle radiation therapy system.
Definition Verify radiation dose to organs from external radiation therapy.
Physical State glass encapsulated electronics
Technical Method Radiation causes change in MOSFET diode that is perportional to dose which can be interigated by external reader.
Target Area Radiation therapy target organ
Regulation Medical Specialty Radiology
Review Panel Radiology
Product CodeNZT
Premarket Review Office of Radiological Health (OHT8)
Division of Radiological Imaging and Radiation Therapy Devices (DHT8C)
Submission Type 510(k)
Regulation Number 892.5050
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? Yes
Life-Sustain/Support Device? No
Recognized Consensus Standards
Third Party Review Not Third Party Eligible