Product Classification

• Device: coil, magnetic resonance, specialty
• Regulation Description: Magnetic resonance diagnostic device.
• Regulation Medical Specialty: Radiology
• Review Panel: Radiology
• Product Code: MOS
• 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

• NEMA MS 10-2006 Determination of Local Specific Absorption Rate (SAR) in Diagnostic Magnetic Resonance Imaging
• NEMA MS 11-2006 Determination of Gradient-Induced Electric Fields in Diagnostic Magnetic Resonance Imaging
• NEMA MS 6-2008 Determination of Signal-to-Noise Ratio and Image Uniformity for Single-Channel Non-Volume Coils in Diagnostic MR Imaging
• IEC 60601-2-33 Edition 3.0 2010-03 Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnostic
• NEMA MS 5-2010 Determination of Slice Thickness in Diagnostic Magnetic Resonance Imaging
• NEMA MS 4-2010 Acoustic Noise Measurement Procedure for Diagnosing Magnetic Resonance Imaging Devices
• NEMA MS 12-2010 Quantification and Mapping of Geometric Distortion for Special Applications
• NEMA MS-1-2008 Determination of Signal-to-Noise Ratio (SNR) in Diagnostic Magnetic Resonance Imaging
• IEC 60601-2-33 (2008) Medical electrical equipment - Part 2-33: Particular requirements for the safety of magnetic resonance equipment for medical diagnosis Consolidated Edition 2.2

Guidance Document

• Guidance for the Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices; Final

Third Party Review

• Eligible for Accredited Persons Program

Accredited Persons

• bsi healthcare
• center for measurement standards of industrial
• dekra certification b.v.
• intertek testing services
• pharmalink technical group, llc
• regulatory technology services, llc
• tuv sud america inc.
• underwriters laboratories, inc.