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U.S. Department of Health and Human Services

Product Classification

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Device system, image processing, radiological
Regulation Description Medical image management and processing system.
Regulation Medical Specialty Radiology
Review Panel Radiology
Product CodeLLZ
Premarket Review Office of Radiological Health (OHT8)
Radiological Imaging Devices and Electronic Products (DHT8B)
Submission Type 510(k)
Regulation Number 892.2050
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
Third Party Review
Accredited Persons
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