Product Classification

• Device: system, nuclear magnetic resonance imaging
• Regulation Description: Magnetic resonance diagnostic device.
• Regulation Medical Specialty: Radiology
• Review Panel: Radiology
• Product Code: LNH
• 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

• 12-187 NEMA MS 3-2008 (R2020)
  Determination of Image Uniformity in Diagnostic Magnetic Resonance Images
• 12-188 NEMA MS-1-2008 (R2020)
  Determination of Signal-to-Noise Ratio (SNR) in Diagnostic Magnetic Resonance Imaging
• 12-195 NEMA MS 6-2008 (R2014, R2020)
  Determination of Signal-to-Noise Ratio and Image Uniformity for Single-Channel Non-Volume Coils in Diagnostic MR Imaging
• 12-196 NEMA MS 2-2008 (R2020)
  Determination of Two-Dimensional Geometric Distortion in Diagnostic Magnetic Resonance Images
• 12-232 NEMA MS 4-2010
  Acoustic Noise Measurement Procedure for Diagnosing Magnetic Resonance Imaging Devices
• 12-264 NEMA MS 11-2010
  Determination of Gradient-Induced Electric Fields in Diagnostic Magnetic Resonance Imaging
• 12-288 NEMA MS 9-2008 (R2020)
  Standards Publication Characterization of Phased Array Coils for Diagnostic Magnetic Resonance Images
• 12-292 IEEE Std 3333.2.1-2015
  IEEE Recommended Practice for Three-Dimensional (3D) Medical Modeling
• 12-295 IEC 60601-2-33 Ed. 3.2 b:2015
  Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis
• 12-298 NEMA MS 10-2010
  Determination of Local Specific Absorption Rate (SAR) in Diagnostic Magnetic Resonance Imaging
• 12-306 NEMA MS 12-2016
  Quantification and Mapping of Geometric Distortion for Special Applications
• 12-315 NEMA MS 8-2016
  Characterization of the Specific Absorption Rate (SAR) for Magnetic Resonance Imaging Systems
• 12-322 NEMA MS 5-2018
  Determination of Slice Thickness in Diagnostic Magnetic Resonance Imaging
• 12-331 NEMA Standards Publication MS 14-2019
  Characterization of Radiofrequency (RF) Coil Heating in Magnetic Resonance Imaging Systems
• 12-332 IEC 62464-1 Edition 2.0 2018-12
  Magnetic resonance equipment for medical imaging Part 1: Determination of essential image quality parameters.
• 12-347 IEC 60601-2-33 Edition 4.0 2022-08
  Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis
• 12-354 NEMA MS 4-2023
  Acoustic Noise Measurement Procedure for Diagnosing Magnetic Resonance Imaging Devices

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

• Eligible for 510(k) Third Party Review Program

Accredited Persons

• beanstock consulting
• center for measurement standards of industrial
• global quality and regulatory services
• regulatory technology services, llc
• third party review group, llc