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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 Code

LNH

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 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 Accredited Persons Program

Accredited Persons

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