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U.S. Department of Health and Human Services

Product Classification

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Device solid state x-ray imager (flat panel/digital imager)
Regulation Description Stationary x-ray system.
Regulation Medical Specialty Radiology
Review Panel Radiology
Product CodeMQB
Premarket Review Division of Radiological Health (DRH)
Division of Radiological Health (DRH)
Submission Type 510(k)
Regulation Number 892.1680
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Eligible
Recognized Consensus Standards
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review
Accredited Persons
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