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) |
|---|---|---|---|
| Feb 22, 2019 | Philips Medical Systems Nederlands SmartPath to dStream for XR and 3.0T, Model Number 781270. Nuclear Magnetic Resonance Imaging System Terminated |
LNH | None listed |
| Feb 22, 2019 | Philips Medical Systems Nederlands Ingenia 1.5T CX (ZBO), Model Number 781262. Nuclear Magnetic Resonance Imaging System Terminated |
LNH | K162931 |
| Feb 22, 2019 | Philips Medical Systems Nederlands Ingenia 1.5T CX, Model Number 781261. Nuclear Magnetic Resonance Imaging System Terminated |
LNH | K162931 |
| Feb 22, 2019 | Philips Medical Systems Nederlands SmartPath to dStream for 1.5T, Model Number 781260. Nuclear Magnetic Resonance Imaging System Terminated |
LNH | None listed |
| Feb 22, 2019 | Philips Medical Systems Nederlands Achieva XR 1.5T/3.0T , Model Number 781253. Nuclear Magnetic Resonance Imaging System Terminated |
LNH | K052013 |
| Feb 22, 2019 | Philips Medical Systems Nederlands Panorama 1.0T, Model Number 781250. Nuclear Magnetic Resonance Imaging System Terminated |
LNH | K041602 |
| Feb 22, 2019 | Philips Medical Systems Nederlands Achieva 7.0T, Model Number 781240. Nuclear Magnetic Resonance Imaging System Terminated |
LNH | K043147 |
| Feb 22, 2019 | Philips Medical Systems Nederlands Achieva 1.5T High Performance, Model Number 781196. Nuclear Magnetic Resonance Imaging System Terminated |
LNH | K052013 |
| Feb 22, 2019 | Philips Medical Systems Nederlands Intera 1.5T, Model Number 781195. Nuclear Magnetic Resonance Imaging System Terminated |
LNH | K052013 |
| Feb 22, 2019 | Philips Medical Systems Nederlands Achieva 1.5T, Model Number 781178. Nuclear Magnetic Resonance Imaging System Terminated |
LNH | K052013 |
| Feb 22, 2019 | Philips Medical Systems Nederlands Achieva 3.0T, Model Number 781177. Nuclear Magnetic Resonance Imaging System Terminated |
LNH | K043147 |
| Feb 22, 2019 | Philips Medical Systems Nederlands Intera Achieva 1.5T IT Nova Dual, Model Number 781176. Nuclear Magnetic Resonance Imaging System Terminated |
LNH | K052013 |
| Feb 22, 2019 | Philips Medical Systems Nederlands Intera Achieva 1.5T IT Nova, Model Number 781175. Nuclear Magnetic Resonance Imaging System Terminated |
LNH | K052013 |
| Feb 22, 2019 | Philips Medical Systems Nederlands Intera 1.5T Achieva CV Nova, Model Number 781174. Nuclear Magnetic Resonance Imaging System Terminated |
LNH | K052013 |
| Feb 22, 2019 | Philips Medical Systems Nederlands Intera Achieva 1.5T Nova Dual, Model Number 781173. Nuclear Magnetic Resonance Imaging System Terminated |
LNH | K052013 |
| Feb 22, 2019 | Philips Medical Systems Nederlands Intera Achieva 1.5T Nova, Model Number 781172. Nuclear Magnetic Resonance Imaging System Terminated |
LNH | K052013 |
| Feb 22, 2019 | Philips Medical Systems Nederlands Intera Achieva 1.5T Pulsar, Model Number 781171. Nuclear Magnetic Resonance Imaging System Terminated |
LNH | K052013 |
| Feb 22, 2019 | Philips Medical Systems Nederlands Intera 1.5T R11, Model Number 781170. Nuclear Magnetic Resonance Imaging System Terminated |
LNH | K030520 |
| Feb 22, 2019 | Philips Medical Systems Nederlands Intera IT, Model Number 781160. Nuclear Magnetic Resonance Imaging System Terminated |
LNH | K013344 |
| Feb 22, 2019 | Philips Medical Systems Nederlands Achieva XR 1.5T/3.0T, Model Number 781153. Nuclear Magnetic Resonance Imaging System Terminated |
LNH | K043147 |
| Feb 22, 2019 | Philips Medical Systems Nederlands Intera 3.0T Master/Quasar Dual, Model Number 781150. Nuclear Magnetic Resonance Imaging System Terminated |
LNH | K030520 |
| Feb 22, 2019 | Philips Medical Systems Nederlands Enterprise 1.5T, Model Number 781145. Nuclear Magnetic Resonance Imaging System Terminated |
LNH | None listed |
| Feb 22, 2019 | Philips Medical Systems Nederlands Intera 1.5T Explorer/Nova Dual, Model Number 781108. Nuclear Magnetic Resonance Imaging System Terminated |
LNH | K030520 |
| Feb 22, 2019 | Philips Medical Systems Nederlands Intera 1.5T CV, Model Number 781107. Nuclear Magnetic Resonance Imaging System Terminated |
LNH | K030520 |
| Feb 22, 2019 | Philips Medical Systems Nederlands Intera 1.5T Master/Nova, Model Number 781106. Nuclear Magnetic Resonance Imaging System Terminated |
LNH | K030520 |
| Feb 22, 2019 | Philips Medical Systems Nederlands Intera 1.5T Power/Pulsar, Model Number 781105. Nuclear Magnetic Resonance Imaging System Terminated |
LNH | K030520 |
| Feb 22, 2019 | Philips Medical Systems Nederlands Intera 1.5T Omni/Stellar, Model Number 781104. Nuclear Magnetic Resonance Imaging System Terminated |
LNH | K030520 |
| Feb 22, 2019 | Philips Medical Systems Nederlands Intera 1.0T Power/Pulsar, Model Number 781103. Nuclear Magnetic Resonance Imaging System Terminated |
LNH | K052078 |
| Feb 22, 2019 | Philips Medical Systems Nederlands Intera 1.0T Omni/Stellar, Model Number 781102. Nuclear Magnetic Resonance Imaging System Terminated |
LNH | K052078 |
| Feb 22, 2019 | Philips Medical Systems Nederlands Intera 0.5T Standard, Model Number 781101. Nuclear Magnetic Resonance Imaging System Terminated |
LNH | K030520 |
| Feb 22, 2019 | Philips Medical Systems Nederlands Multiva 1.5T 16 R5, Model Number 781078. Nuclear Magnetic Resonance Imaging System Terminated |
LNH | None listed |
| Feb 22, 2019 | Philips Medical Systems Nederlands Multiva 1.5T 16 R5 (ZBO), Model Number 781073. Nuclear Magnetic Resonance Imaging System Terminated |
LNH | None listed |
| Feb 22, 2019 | Philips Medical Systems Nederlands Multiva 1.5T 8 R5 (ZBO), Model Number 781072. Nuclear Magnetic Resonance Imaging System Terminated |
LNH | None listed |
| Feb 22, 2019 | Philips Medical Systems Nederlands Prodiva CX, Model Number 781070. Nuclear Magnetic Resonance Imaging System Terminated |
LNH | None listed |
| Feb 22, 2019 | Philips Medical Systems Nederlands Prodiva CS, Model Number 781069. Nuclear Magnetic Resonance Imaging System Terminated |
LNH | None listed |
| Dec 3, 2018 | Philips Medical Systems Nederlands Ingenia Elition S, Ingenia Elition X Terminated |
LNH | K173356 |
| Nov 15, 2018 | GE Healthcare, LLC Various GE Magnetic Resonance System on-site software version
Product Usage:
Magnetic resonance imaging equipment for general diagnostic use Terminated |
LNH | K012200 K013636 +4 |
| Oct 3, 2018 | GE Medical Systems, LLC SIGNA Architect system
Product Usage:
The Signa Architect system is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. It i Terminated |
LNH | K160618 |
| Aug 20, 2018 | NordicNeuroLab AS fMRI Hardware System VisualSystem allows video signals from the stimulus presentation PC to enter the shielded scanner room and presented by a set of coil-mounted displays or by an in-room LCD monit Terminated |
LNH | K092253 |
| Jun 18, 2018 | Hitachi Medical Systems America Inc Hitachi Oasis MRI system
Product Usage:
Hitachi MR system is an imaging device and is intended to provide the physician with physiological and clinical information, obtained non-invasively and withou Terminated |
LNH | K093044 |
| Jun 7, 2018 | GE Medical Systems, LLC GE Healthcare MRI Systems, Software Version 15.x or HD 16 sold under the following product names:
*ER*15T HDXT ECHOSPEED 16 CHANNEL, *OC*1.5T HDX ECHOSPEED 8 CHANNEL, *SC*1.5T HD TO HDX UPGRADE, *T Terminated |
LNH | K012200 K013636 +4 |
| Jun 7, 2018 | GE Medical Systems, LLC GE Healthcare MRI Systems, Software Version 12.x, sold under the following product names:
SIGNA MR/I ECHOSPD W/ EXCITE, 1.5 HISPEED HD 8-CH 400-AP, MR GOLDSEAL 1.5T HD 8CH USED, UPGRADE 1.5 EXC-II Terminated |
LNH | K012200 K013636 +4 |
| Jun 7, 2018 | GE Medical Systems, LLC GE Healthcare MRI Systems, Software Version 11.x, sold under the following product names:
1.5T CXK4 LCC MAGNET,1.5T EXCITE, 1.5T EXCITE E/S, 1.5T EXCITE GS,
1.5T EXCITE HYBRID, 1.5T EXCITE TWIN, 1. Terminated |
LNH | K012200 K013636 +4 |
| Jun 6, 2018 | GE Medical Systems, LLC Discovery MR750w Nuclear Magnetic Resonance Imaging System labeled as the following product name sold under:
Product Name (Model Number):
A. 3.0T MR750 32CH (911000-3);
B. 3.0T MR750W (5911000-3, 5 Terminated |
LNH | K142085 |
| May 30, 2018 | Canon Medical System, USA, INC. Nuclear Magnetic Resonance Imaging Systems that are indicated for use as a diagnostic imaging modality that produces cross-sectional transaxial, coronal, sagittal, and oblique images that display anat Open, Classified |
LNH | K120638 K170412 +1 |
| Apr 18, 2018 | Philips Electronics North America Corporation T5 Model 78104
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 structure of the Terminated |
LNH | K890789 |
| Apr 18, 2018 | Philips Electronics North America Corporation Multiva systems; 1) Magnets Multiva 16 Model 781487, 2) Magnets 8 Model 781488, 3) Magnet Achieva 1.5T, Model 781492, 4) Magnet HFO, Model 781495, 5) Magnet Multiva 16, Model 781496, 6) Magnet Multiva Terminated |
LNH | None listed |
| Apr 18, 2018 | Philips Electronics North America Corporation T10-NT, Model 78107
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 structure of Terminated |
LNH | K945945 |
| Apr 18, 2018 | Philips Electronics North America Corporation ACS-NT, Model 78108
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 structure of Terminated |
LNH | K945945 |
| Apr 18, 2018 | Philips Electronics North America Corporation T5-NT, Model 78104
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 structure of Terminated |
LNH | K945945 |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.