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U.S. Department of Health and Human Services

Product Classification

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Device system, x-ray, angiographic
Regulation Description Angiographic x-ray system.
Regulation Medical Specialty Radiology
Review Panel Radiology
Product CodeIZI
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Division of Radiological Health (DRH)
Submission Type 510(k)
Regulation Number 892.1600
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 Not Third Party Eligible
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