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U.S. Department of Health and Human Services

Product Classification

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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 In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 892.5050
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standards
Third Party Review Not Third Party Eligible
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