ClearanceBrief
Panels › Radiology › Product code LNH · Class 2

System, Nuclear Magnetic Resonance Imaging

Regulation 892.1000

28510(k)s in 12 months (1,110 all time)
60recalls in 12 months (723 all time)
630recalls that name a 510(k)
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Top companies in LNH

DateFirm and productCodeLinked 510(k)
Apr 18, 2018Philips Electronics North America Corporation
Ingenia 1.5T CX, Models 781261 & 781262 Product Usage: Indicated for use as a diagnostic device. It can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the i
Terminated
LNHK162931
Apr 18, 2018Philips Electronics North America Corporation
Conversion SmarthPath to dStream for 1.5T, Model 781260 Product Usage: Indicated for use as a diagnostic device. It can produce cross-sectional images, spectroscopic images and/or spectra in any orie
Terminated
LNHK162931
Apr 18, 2018Philips Electronics North America Corporation
Achieva 1.5T: 1) Nova (Dual), Model 781173, 2) Achieva 1.5T Initial Systems Model 781178, 3) Achieva 1.5T Nova Model 781196, 4) Achieva 1.5T Conversion Model 781283, 5) Achieva 1.5T Model 781296, 6) A
Terminated
LNHK052013
Apr 18, 2018Philips Electronics North America Corporation
Panorama 1.0T, Model 781250 Product Usage: Indicated for use as a diagnostic device. It can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal stru
Terminated
LNHK041602
Apr 18, 2018Philips Electronics North America Corporation
Intera 1.5T; 1) Intera 1.5T Omni/Stellar Model 781104, 2) Intera 1.5T Power/Pulsar Model 781105, 3) Intera 1.5T Master/Nova Model 781106, 4) Intera 1.5T Master CV Model 781107, 5) Intera 1.5T Explore
Terminated
LNHK052013
Apr 18, 2018Philips Electronics North America Corporation
Intera 1.0T; 1) Stellar Model 781102, 2) Pular Model 781103 Product Usage: Indicated for use as a diagnostic device. It can produce cross-sectional images, spectroscopic images and/or spectra in any
Terminated
LNHK030520
Apr 18, 2018Philips Electronics North America Corporation
Intera 0.5T Standard, Model 781101 Product Usage: Indicated for use as a diagnostic device. It can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the intern
Terminated
LNHK030520
Apr 18, 2018Philips Electronics North America Corporation
Multiva systems, 1) Multiva 1.5T 8 R5 Model 781072, 2) Multiva 1.5T 16 R5 Model 781073, 3) Multiva 1.5T 8ch R5 based Model 781074, 4) Multiva 1.5T Model 781076, & 5) Multiva 1.5T 16ch R5 based Model 7
Terminated
LNHNone listed
Apr 4, 2018Deerfield Imaging, Inc.
IMRIS IMRI 1.5T AND 3T S System Product Usage: The IMRIS intraoperative MRI systems are traditional MRI systems that have been suspended on an overhead rail system. and is designated to operative ins
Terminated
LNHK133692
Mar 30, 2018GE Medical Systems, LLC
MR Surgical Suite Option Product The MR Surgical Option when integrated with the GE Signa 3.0T or 1.5T magnetic resonance scanner (previously cleared K041476) can be used to produce head and whole bo
Terminated
LNHK041476
Oct 28, 2017NordicNeuroLab AS
fMRI Hardware System - AudioSystem, Version 1.0 The AudioSystem allows auditory signals from the stimulus presentation PC to enter the scanner room and to be presented to the patient. A communication
Terminated
LNHK080515
Aug 2, 2017GE Medical Systems, LLC
Signa PET/MR (K163619, K142098) Product Usage: The SIGNA PET/MR system combines magnetic resonance diagnostic devices (MRDD) and Positron Emission Tomography (PET) scanners that provide registrati
Terminated
LNHK142098
K163619
Aug 2, 2017GE Medical Systems, LLC
1.5T Signa HDxt, 3.0T Signa HDxt, Signa HDi, Signa Vibrant Product Usage: The 1.5T Signa HDx family and 3.0T Signa HDx family are a whole body magnetic resonance scanner designed to support high
Terminated
LNHK121676
Aug 2, 2017GE Medical Systems, LLC
1.5T Signa HDx, 3.0T Signa HDx, 1.5T Signa HDxt, 3.0T Signa HDxt, Signa HDi, Signa Vibrant Product Usage: The GE Signa HDx MR system is a whole body magnetic resonance scanner designed to support
Terminated
LNHK052293
Aug 2, 2017GE Medical Systems, LLC
SIGNA Creator, SIGNA ExplorerProduct Usage: 1.5T SIGNA Creator and 1.5T SIGNA Explorer is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and
Terminated
LNHK143251
Aug 2, 2017GE Medical Systems, LLC
Discovery MR750 3.0T Product Usage: Intended use: The Discovery MR750 3.0Tsystem is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and sho
Terminated
LNHK081028
K132376 +3
Aug 2, 2017GE Medical Systems, LLC
Optima MR450w 1.5T Product Usage: The Optima MR450w 1.5T system is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. It
Terminated
LNHK091536
K113490 +4
Aug 2, 2017GE Medical Systems, LLC
Optima MR750 3.0T Product Usage: The Optima MR450 1.5T system is a whole body magnetic resonance scanner designed to support high resolution, high signal-to noise ratio, and short scan times. It
Terminated
LNHK083147
K132376 +2
Aug 2, 2017GE Medical Systems, LLC
Optima MR450 1.5T Product Usage: 1 .5T Brivo MR355 and 1.5T Optima MR360 are whole body magnetic resonance scanners designed to support high resolution, high signal-to-noise ratio, and short scan
Terminated
LNHK083147
K132376 +2
Aug 2, 2017GE Medical Systems, LLC
Brivo MR355, Optima MR360 Product Usage: The Brivo MR355/Optima MR360 is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan tim
Terminated
LNHK103330
K120778 +1
Mar 23, 2017Hitachi Medical Systems America Inc
Hitachi Echelon MRI System
Terminated
LNHK083533
Mar 23, 2017Hitachi Medical Systems America Inc
Hitachi Echelon Oval MRI System
Terminated
LNHK113145
K151015 +1
Mar 23, 2017Hitachi Medical Systems America Inc
Hitachi Oasis MRI System
Terminated
LNHK153547
Feb 10, 2017GE Healthcare, LLC
Discovery MR450 The systems are whole body magnetic resonance scanners designed to support high resolution, high signal-to-noise ratio, and short scan times. It is indicated for use as a diagnostic i
Terminated
LNHK132376
K142085 +1
Jan 6, 2017Hitachi Medical Systems America Inc
Hitachi Oasis MRI System - C-Spine Coil
Terminated
LNHK072279
Dec 19, 2016Philips Electronics North America Corporation
Ingenia MR-OR; 781437, 781438 The MR-OR option is intended for allowing transfer of a neurosurgical patient from OR suite to MR suite and back with tools and instructions for proper positioning and MR
Terminated
LNHK110151
Oct 17, 2016Siemens Medical Solutions USA, Inc
Combi Dockable Neurosurgery table for the Siemens MAGNETOM Aera (1.5T) and Skyra (3T) MRI Systems
Terminated
LNHK101347
Aug 31, 2016GE Healthcare, LLC
GE Healthcare SIGNA Creator, SIGNA Explorer. Diagnostic Imaging Device.
Terminated
LNHK143251
Jul 6, 2016Medtronic Navigation
PoleStar system (N20 / N30) Warning Lamps Control Box, Warning Lamps Control Box Cables, Thermoflex Chiller Product The PoleStar Surgical MRI System is intended for use as an intraoperative imaging d
Terminated
LNHK032541
K092308
Jul 6, 2016Toshiba American Medical Systems Inc
MEXL-3010/A5- Vantage Titan 3T Magnetic Resonance Imaging System Product Usage: Vantage Titan 3T (MRT-3010, M-Power V3.5) is an open-bore 3T MRI system that permits outstanding image quality without
Terminated
LNHK152371
Jul 5, 2016Esaote S.p.A.
Magnetic Resonance System G-scan Brio (Part Number /Model No.101002000)
Terminated
LNHK142421
Jun 8, 2016GE Healthcare, LLC
GE Healthcare, Discovery MR750w
Terminated
LNHK103327
K130115 +2
Jun 8, 2016GE Healthcare, LLC
Optima 1.5T MR430s MR Scanner, a diagnostic imaging device
Terminated
LNHK123068
Jun 8, 2016GE Healthcare, LLC
MSK 1.5T Extreme MR Scanner, a diagnostic imaging device
Terminated
LNHK080048
May 3, 2016Siemens Medical Solutions USA, Inc
MAGNETOM Aera/Skyra Systems, whole body magnetic resonance imaging systems, Model numbers 10432914, 10432915. Docking station top cover (part no# 10591430) of the removable patient table.
Terminated
LNHK101347
Mar 11, 2016Deerfield Imaging
Intra operative MRI Systems: Neuro II-SE , Neuro III-SV, iMRI 1.5T A, and iMRI 3T S. Indicated for use as a magnetic resonance diagnostic device (MRDD).
Terminated
LNHK061916
K071099 +2
Mar 1, 2016GE Medical Systems, LLC
SIGNA Pioneer MR Systems Product Usage: The SIGNA Pioneer is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. It is indic
Terminated
LNHK143345
Feb 26, 2016Philips Electronics North America Corporation
SENSE Body Coil 1.5T with identification; used in the ACS NT, Intera 1.5T and Achieva 1.5T MR system
Terminated
LNHK001796
K013344 +2
Dec 28, 2015GE Medical Systems, LLC
GE Healthcare, Discovery 3.0T MR750, 5148810-2, 5373011-2, 5499460-2.
Terminated
LNHK081028
K132376 +2
Dec 22, 2015Siemens Medical Solutions USA, Inc
MAGNETOM systems, magnetic resonance diagnostic devices (MRDD).
Terminated
LNHK002179
K032428 +3
Nov 23, 2015Philips Medical Systems, Inc.
Ingenia, Intera, Achieva and Achieve dStream MR systems on Software versions R5.1.7 and R5.1.8 with the Mobi View software option. Diagnostic imaging system.
Terminated
LNHK063559
K110151
Nov 10, 2015GE Healthcare
GE Healthcare, SIGNA HDxt 3.0T. Product Usage: The 1.5T Signa HDx family and 3.0T Signa HDx family are a whole body magnetic resonance scanner for use as a diagnostic imaging device.
Terminated
LNHK052293
K132376
Nov 10, 2015GE Healthcare
GE Healthcare, SIGNA HDx 3.0T. Product Usage: The GE Signa HDx MR system is a whole body magnetic resonance scanner for use as a diagnostic imaging device.
Terminated
LNHK052293
Nov 10, 2015GE Healthcare
GE Healthcare, SIGNA HD 3.0T. Product Usage: The Signa Profile EXCITE MR system is an open, whole body scanner for use as a diagnostic imaging device. It may be utilized for imaging during interventi
Terminated
LNHK041476
Nov 10, 2015GE Healthcare
GE Healthcare, SIGNA Excite 3.0T. MR System for use as a diagnostic imaging device.
Terminated
LNHK040444
Nov 10, 2015GE Healthcare
GE Healthcare, SIGNA 3.0T. Product Usage: Magnetic resonance system for diagnostic imaging. The indications for use for the 3.0T Signa VH/i (Signa 3.0T MR System) Transmit/Receive Body Imaging Coil
Terminated
LNHK013636
Nov 10, 2015GE Healthcare
GE Healthcare, Discovery MR750w 3.0T. Product Usage: The Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T and the Optima MR450w 1.5T Systems are whole body magnetic resonance scanne
Terminated
LNHK132376
Oct 30, 2015GE Medical Systems, LLC
MR Surgical Suite II Table, Model Number(s): M8074SS, M8053SS, M0074SS. UPDATE 11-4-2015: Model M0001SS
Terminated
LNHK043262
Aug 5, 2015GE Healthcare
GE Healthcare, Signa Infinity MR System; Signa MR/i MR System; SmartSpeed; EchoSpeed Plus; HighSpeed Plus, Signa Infinity MR System with EXCITE Technology, Excite II, Signa 3T Infinity with Excite, Si
Terminated
LNHK012200
K013636 +3
Jul 22, 2015Philips Electronics North America Corporation
Pinnacle3 Software Version 9.0, 9.2, 9.4 and 9.6, Model Numbers 453560446041, 459800091001, 459800220161, 459800232931, 459800235871, 459800338451. UPDATED: Pinnacle3 Software Version 8.0h, 8.0k
Terminated
LNHK041577

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