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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 Radiological Health (OHT8)
Radiological Imaging and Radiation Therapy Devices (DHT8C)
Submission Type 510(k)
Regulation Number 892.1000
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
Guidance Documents
Third Party Review
Accredited Persons
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