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)
Top companies in LNH
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 18, 2018 | Philips 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 |
LNH | K162931 |
| Apr 18, 2018 | Philips 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 |
LNH | K162931 |
| Apr 18, 2018 | Philips 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 |
LNH | K052013 |
| Apr 18, 2018 | Philips 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 |
LNH | K041602 |
| Apr 18, 2018 | Philips 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 |
LNH | K052013 |
| Apr 18, 2018 | Philips 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 |
LNH | K030520 |
| Apr 18, 2018 | Philips 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 |
LNH | K030520 |
| Apr 18, 2018 | Philips 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 |
LNH | None listed |
| Apr 4, 2018 | Deerfield 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 |
LNH | K133692 |
| Mar 30, 2018 | GE 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 |
LNH | K041476 |
| Oct 28, 2017 | NordicNeuroLab 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 |
LNH | K080515 |
| Aug 2, 2017 | GE 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 |
LNH | K142098 K163619 |
| Aug 2, 2017 | GE 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 |
LNH | K121676 |
| Aug 2, 2017 | GE 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 |
LNH | K052293 |
| Aug 2, 2017 | GE 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 |
LNH | K143251 |
| Aug 2, 2017 | GE 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 |
LNH | K081028 K132376 +3 |
| Aug 2, 2017 | GE 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 |
LNH | K091536 K113490 +4 |
| Aug 2, 2017 | GE 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 |
LNH | K083147 K132376 +2 |
| Aug 2, 2017 | GE 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 |
LNH | K083147 K132376 +2 |
| Aug 2, 2017 | GE 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 |
LNH | K103330 K120778 +1 |
| Mar 23, 2017 | Hitachi Medical Systems America Inc Hitachi Echelon MRI System Terminated |
LNH | K083533 |
| Mar 23, 2017 | Hitachi Medical Systems America Inc Hitachi Echelon Oval MRI System Terminated |
LNH | K113145 K151015 +1 |
| Mar 23, 2017 | Hitachi Medical Systems America Inc Hitachi Oasis MRI System Terminated |
LNH | K153547 |
| Feb 10, 2017 | GE 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 |
LNH | K132376 K142085 +1 |
| Jan 6, 2017 | Hitachi Medical Systems America Inc Hitachi Oasis MRI System - C-Spine Coil Terminated |
LNH | K072279 |
| Dec 19, 2016 | Philips 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 |
LNH | K110151 |
| Oct 17, 2016 | Siemens Medical Solutions USA, Inc Combi Dockable Neurosurgery table for the Siemens MAGNETOM Aera (1.5T) and Skyra (3T) MRI Systems Terminated |
LNH | K101347 |
| Aug 31, 2016 | GE Healthcare, LLC GE Healthcare SIGNA Creator, SIGNA Explorer. Diagnostic Imaging Device. Terminated |
LNH | K143251 |
| Jul 6, 2016 | Medtronic 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 |
LNH | K032541 K092308 |
| Jul 6, 2016 | Toshiba 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 |
LNH | K152371 |
| Jul 5, 2016 | Esaote S.p.A. Magnetic Resonance System G-scan Brio (Part Number /Model No.101002000) Terminated |
LNH | K142421 |
| Jun 8, 2016 | GE Healthcare, LLC GE Healthcare, Discovery MR750w Terminated |
LNH | K103327 K130115 +2 |
| Jun 8, 2016 | GE Healthcare, LLC Optima 1.5T MR430s MR Scanner, a diagnostic imaging device Terminated |
LNH | K123068 |
| Jun 8, 2016 | GE Healthcare, LLC MSK 1.5T Extreme MR Scanner, a diagnostic imaging device Terminated |
LNH | K080048 |
| May 3, 2016 | Siemens 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 |
LNH | K101347 |
| Mar 11, 2016 | Deerfield 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 |
LNH | K061916 K071099 +2 |
| Mar 1, 2016 | GE 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 |
LNH | K143345 |
| Feb 26, 2016 | Philips 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 |
LNH | K001796 K013344 +2 |
| Dec 28, 2015 | GE Medical Systems, LLC GE Healthcare, Discovery 3.0T MR750, 5148810-2, 5373011-2, 5499460-2. Terminated |
LNH | K081028 K132376 +2 |
| Dec 22, 2015 | Siemens Medical Solutions USA, Inc MAGNETOM systems, magnetic resonance diagnostic devices (MRDD). Terminated |
LNH | K002179 K032428 +3 |
| Nov 23, 2015 | Philips 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 |
LNH | K063559 K110151 |
| Nov 10, 2015 | GE 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 |
LNH | K052293 K132376 |
| Nov 10, 2015 | GE 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 |
LNH | K052293 |
| Nov 10, 2015 | GE 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 |
LNH | K041476 |
| Nov 10, 2015 | GE Healthcare GE Healthcare, SIGNA Excite 3.0T. MR System for use as a diagnostic imaging device. Terminated |
LNH | K040444 |
| Nov 10, 2015 | GE 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 |
LNH | K013636 |
| Nov 10, 2015 | GE 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 |
LNH | K132376 |
| Oct 30, 2015 | GE Medical Systems, LLC MR Surgical Suite II Table, Model Number(s): M8074SS, M8053SS, M0074SS.
UPDATE 11-4-2015: Model M0001SS Terminated |
LNH | K043262 |
| Aug 5, 2015 | GE 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 |
LNH | K012200 K013636 +3 |
| Jul 22, 2015 | Philips 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 |
LNH | K041577 |
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