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U.S. Department of Health and Human Services

Product Classification

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Device system, nuclear magnetic resonance imaging
Regulation Description Magnetic resonance diagnostic device.
Regulation Medical Specialty Radiology
Review Panel Radiology
Product CodeLNH
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 892.1000
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standards
Guidance Documents
  • Criteria for Significant Risk Investigations of Magnetic Resonance Diagnostic Devices - Guidance for Industry and FDA Staff
  • Guidance for the Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices; Final
Third Party Review
Accredited Persons

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