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U.S. Department of Health and Human Services

Product Classification

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Device system, tomography, computed, emission
Regulation Description Emission computed tomography system.
Regulation Medical Specialty Radiology
Review Panel Radiology
Product CodeKPS
Premarket Review Office of Radiological Health (OHT8)
Radiological Imaging and Radiation Therapy Devices (DHT8C)
Submission Type 510(k)
Regulation Number 892.1200
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
Guidance Document
Third Party Review
Accredited Persons
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