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U.S. Department of Health and Human Services

Product Classification

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Device system, x-ray, tomography, computed
Regulation Description Computed tomography x-ray system.
Regulation Medical Specialty Radiology
Review Panel Radiology
Product CodeJAK
Premarket Review Office of Radiological Health (OHT8)
Radiological Imaging Devices and Electronic Products (DHT8B)
Submission Type 510(k)
Regulation Number 892.1750
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 Standards
Guidance Document
Third Party Review
Accredited Persons
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