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Device
coil, magnetic resonance, specialty
Regulation Description
Magnetic resonance diagnostic device.
Regulation Medical Specialty
Radiology
Review Panel
Radiology
Product Code
MOS
Premarket Review
Office of Radiological Health
(OHT8)
Division of 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
12-295 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
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
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