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U.S. Department of Health and Human Services

Product Classification

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Device system, x-ray, photofluorographic
Regulation Description Photofluorographic x-ray system.
Regulation Medical Specialty Radiology
Review Panel Radiology
Product CodeIZG
Premarket Review Division of Radiological Health (DRH)
Division of Radiological Health (DRH)
Submission Type 510(k)
Regulation Number 892.1730
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
Third Party Review
Accredited Persons
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