Coil, Magnetic Resonance, Specialty

Device Code: 5391

Product Code(s): MOS

Device Classification Information

• Device Type ID: 5391
• Device Name: Coil, Magnetic Resonance, Specialty
• Regulation Description: Magnetic Resonance Diagnostic Device.
• Regulation Medical Specialty: Radiology
• Review Panel: Radiology
• Premarket Review: Office Of In Vitro Diagnostics And Radiological Health (OIR)
• Submission Type: 510(k)
• CFR Regulation Number: 892.1000 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: MOS
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Eligible For Accredited Persons Program

Recognized 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
• 12-231 NEMA MS 5-2010
  Determination Of Slice Thickness In Diagnostic Magnetic Resonance Imaging
• 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

Total Product Life Cycle

• Device Type ID: 5391
• Device: Coil, Magnetic Resonance, Specialty
• Product Code: MOS
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Magnetic Resonance Diagnostic Device.
• CFR Regulation Number: 892.1000 [🔎]

Premarket Reviews
Manufacturer	Decision
GE HEALTHCARE
	SUBSTANTIALLY EQUIVALENT	1
GE HEALTHCARE COILS (USA INSTRUMENTS INC.)
	SUBSTANTIALLY EQUIVALENT	1
GENERAL ELECTRIC CO.
	SUBSTANTIALLY EQUIVALENT	1
HITACHI MEDICAL CORP.
	SUBSTANTIALLY EQUIVALENT	1
HITACHI MEDICAL SYSTEMS AMERICA, INC.
	SUBSTANTIALLY EQUIVALENT	1
INVIVO
	SUBSTANTIALLY EQUIVALENT	2
INVIVO THERAPEUTICS CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
LMT MEDICAL SYSTEMS GMBH
	SUBSTANTIALLY EQUIVALENT	1
MONTERIS MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
NEOCOIL, LLC
	SUBSTANTIALLY EQUIVALENT	3
NORAS MRI PRODUCTS GMBH
	SUBSTANTIALLY EQUIVALENT	2
NORAS RONTGEN-UND MEDIZINTECHNIK GMBH
	SUBSTANTIALLY EQUIVALENT	1
PHILIPS MEDICAL SYSTEMS INTERNATIONAL BV
	SUBSTANTIALLY EQUIVALENT	2
QUALITY ELECTRODYNAMICS, LLC.
	SUBSTANTIALLY EQUIVALENT	3
RAPID BIOMEDICAL GMBH
	SUBSTANTIALLY EQUIVALENT	2
RESONANCE INNOVATIONS LLC
	SUBSTANTIALLY EQUIVALENT	5

Device Problems
Coil	1
Positioning Problem	1
Insufficient Information	1
Device Operates Differently Than Expected	1
Total Device Problems	4

Recalls
Manufacturer		Recall Class	Date Posted
1	GE Medical Systems, LLC	II	Dec-28-2015
2	Hitachi Medical Systems America Inc	II	Aug-10-2015
3	Invivo Corporation	II	Aug-30-2016
4	NeoCoil, LLC	II	Aug-01-2016
5	NeoCoil, LLC	II	Feb-29-2016

TPLC Last Update: 2019-04-02 21:05:26