Product Classification

• Device: system, nuclear magnetic resonance spectroscopic
• Regulation Description: Magnetic resonance diagnostic device.
• Regulation Medical Specialty: Radiology
• Review Panel: Radiology
• Product Code: LNI
• 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
• Summary Malfunction Reporting: Eligible

Recognized Consensus Standards

• 12-187 NEMA MS 3-2008 (R2014)
  Determination of Image Uniformity in Diagnostic Magnetic Resonance Images
• 12-188 NEMA MS-1-2008 (R2014)
  Determination of Signal-to-Noise Ratio (SNR) in Diagnostic Magnetic Resonance Imaging
• 12-195 NEMA MS 6-2008 (R2014)
  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 (R2014)
  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 (R2014)
  Standards Publication Characterization of Phased Array Coils for Diagnostic Magnetic Resonance Images
• 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 XS 14-2019
  Characterization of Radiofrequency (RF) Coil Heating in Magnetic Resonance Imaging Systems

• Implanted Device?: No
• Life-Sustain/Support Device?: No

Third Party Review

• Eligible for Accredited Persons Program

Accredited Persons

• accelerated device approval services, llc
• biomarkers and diagnostics consulting, llc
• center for measurement standards of industrial
• regulatory technology services, llc
• third party review group, llc