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) |
|---|---|---|---|
| Dec 23, 2021 | GE Healthcare, LLC GE Healthcare MR superconducting magnets, a component of GE Healthcare Discovery MR750w 3.0T System, nuclear magnetic resonance imaging system. Open, Classified |
LNH | K132376 K142085 +2 |
| Dec 23, 2021 | GE Healthcare, LLC GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Pioneer System, nuclear magnetic resonance imaging system. Open, Classified |
LNH | K143345 K153003 +1 |
| Dec 23, 2021 | GE Healthcare, LLC GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Architect system, nuclear magnetic resonance imaging system. Open, Classified |
LNH | K160618 K163331 +1 |
| Dec 23, 2021 | GE Healthcare, LLC GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Premier System, nuclear magnetic resonance imaging system. Open, Classified |
LNH | K171128 K183231 +1 |
| Oct 16, 2021 | GE Healthcare, LLC 1.5T SIGNA HDxt MR System nuclear magnetic resonance imaging system Terminated |
LNH | K052293 K121676 |
| Oct 16, 2021 | GE Healthcare, LLC Optima MR450w 1.5T nuclear magnetic resonance imaging system Terminated |
LNH | K142085 K160618 +1 |
| Oct 16, 2021 | GE Healthcare, LLC SIGNA Artist nuclear magnetic resonance imaging system Terminated |
LNH | K160618 K163331 +1 |
| Oct 16, 2021 | GE Healthcare, LLC SIGNA Voyager nuclear magnetic resonance imaging system Terminated |
LNH | K161567 K192426 |
| Oct 16, 2021 | GE Healthcare, LLC SIGNA Creator, SIGNA Explorer nuclear magnetic resonance imaging system Terminated |
LNH | K143251 |
| Oct 16, 2021 | GE Healthcare, LLC Discovery MR750 3.0T nuclear magnetic resonance imaging system Terminated |
LNH | K142085 K160618 +1 |
| Oct 16, 2021 | GE Healthcare, LLC Discovery MR750w 3.0T nuclear magnetic resonance imaging system Terminated |
LNH | K142085 K160618 +1 |
| Oct 16, 2021 | GE Healthcare, LLC SIGNA Pioneer nuclear magnetic resonance imaging system Terminated |
LNH | K143345 K153003 +1 |
| Oct 16, 2021 | GE Healthcare, LLC SIGNA Architect nuclear magnetic resonance imaging system Terminated |
LNH | K160618 K163331 +1 |
| Oct 16, 2021 | GE Healthcare, LLC SIGNA Premier nuclear magnetic resonance imaging system Terminated |
LNH | K171128 K183231 +1 |
| Sep 10, 2021 | Siemens Medical Solutions USA, Inc MR MAGNETOM Systems with RT Image Suite with syngo MR VA20A, VA30A and VA31A with license SW-Key CT_RT_IMA_SUITE_SYNTHETIC_CT
Material Numbers: 11060815 Open, Classified |
LNH | K203443 |
| Aug 11, 2021 | Philips North America Llc Ingenia Ambition X- Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any or Completed |
LNH | K181479 |
| Aug 11, 2021 | Philips North America Llc SmartPath to dStream for XR and 3.0T-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/o Completed |
LNH | K162931 |
| Aug 11, 2021 | Philips North America Llc Ingenia 3.0T CX-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orie Completed |
LNH | K162931 |
| Aug 11, 2021 | Philips North America Llc Ingenia Elition X-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any or Completed |
LNH | K173451 |
| Aug 11, 2021 | Philips North America Llc Ingenia Elition S-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any or Completed |
LNH | K173451 |
| Aug 11, 2021 | Philips North America Llc Ingenia 3.0T-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orienta Completed |
LNH | K163116 |
| Aug 11, 2021 | Philips North America Llc Ingenia Ambition S-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any o Completed |
LNH | K181479 |
| Aug 11, 2021 | Philips North America Llc SmartPath to dStream for 1.5T-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spect Completed |
LNH | K162931 |
| Aug 11, 2021 | Philips North America Llc Ingenia 1.5T CX-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orie Completed |
LNH | K162931 |
| Aug 11, 2021 | Philips North America Llc Ingenia 1.5T S-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orien Completed |
LNH | K153324 |
| Aug 11, 2021 | Philips North America Llc Ingenia 1.5T Evolution-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in a Completed |
LNH | K162931 |
| Aug 11, 2021 | Philips North America Llc Ingenia 1.5T- a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orient Completed |
LNH | K110151 |
| Jul 30, 2021 | Philips North America Llc Ingenia Elition S-Magnetic Resonance Medical Electrical Systems indicated for use as a
diagnostic device. The system can produce cross-sectional images, spectroscopic images
and/or spectra in any orie Terminated |
LNH | K173451 |
| Jul 30, 2021 | Philips North America Llc Achieva 3.0T-Magnetic Resonance Medical Electrical Systems indicated for use as a
diagnostic device. The system can produce cross-sectional images, spectroscopic images
and/or spectra in any orientati Terminated |
LNH | K110151 |
| Jul 30, 2021 | Philips North America Llc Ingenia CX 3.0T-Magnetic Resonance Medical Electrical Systems indicated for use as a
diagnostic device. The system can produce cross-sectional images, spectroscopic images
and/or spectra in any orient Terminated |
LNH | K162931 |
| Jul 30, 2021 | Philips North America Llc Ingenia Elition X-Magnetic Resonance Medical Electrical Systems indicated for use as a
diagnostic device. The system can produce cross-sectional images, spectroscopic images
and/or spectra in any orie Terminated |
LNH | K173451 |
| Jul 30, 2021 | Philips North America Llc Ingenia 3.0T-Magnetic Resonance Medical Electrical Systems indicated for use as a
diagnostic device. The system can produce cross-sectional images, spectroscopic images
and/or spectra in any orientati Terminated |
LNH | K163116 |
| Jul 30, 2021 | Philips North America Llc Ingenia 1.5T-Magnetic Resonance Medical Electrical Systems indicated for use as a
diagnostic device. The system can produce cross-sectional images, spectroscopic images
and/or spectra in any orientati Terminated |
LNH | K163116 |
| Jul 30, 2021 | Philips North America Llc Ingenia 1.5T Evoluton- Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any Terminated |
LNH | K162931 |
| Jul 29, 2021 | Hitachi Healthcare Americas Corporation OASIS MRI System Terminated |
LNH | K202030 |
| Jul 29, 2021 | Hitachi Healthcare Americas Corporation ECHELON Oval MRI System Terminated |
LNH | K172110 |
| Jul 29, 2021 | Hitachi Healthcare Americas Corporation ECHELON MRI System Terminated |
LNH | K083533 |
| Jul 12, 2021 | GE Healthcare, LLC 1.5T SIGNA HDxt (HD28) MR System, Nuclear Magnetic Resonance Imaging System Open, Classified |
LNH | K052293 K121676 |
| Jul 12, 2021 | GE Healthcare, LLC Discovery MR450 1.5T, Nuclear Magnetic Resonance Imaging System Open, Classified |
LNH | K142085 K160618 +1 |
| Jul 12, 2021 | GE Healthcare, LLC Optima MR450w 1.5T, Nuclear Magnetic Resonance Imaging System Open, Classified |
LNH | K142085 K160618 +1 |
| Jul 12, 2021 | GE Healthcare, LLC SIGNA Voyager, Nuclear Magnetic Resonance Imaging System Open, Classified |
LNH | K161567 K192426 |
| Jul 12, 2021 | GE Healthcare, LLC SIGNA Artist, Nuclear Magnetic Resonance Imaging System Open, Classified |
LNH | K160618 K163331 +1 |
| Jul 12, 2021 | GE Healthcare, LLC SIGNA MR380, Nuclear Magnetic Resonance Imaging System Open, Classified |
LNH | None listed |
| Jul 12, 2021 | GE Healthcare, LLC SIGNA MR355, SIGNA MR360, Nuclear Magnetic Resonance Imaging System Open, Classified |
LNH | K143251 |
| Jul 12, 2021 | GE Healthcare, LLC SIGNA Creator, SIGNA Explorer, Nuclear Magnetic Resonance Imaging System Open, Classified |
LNH | K143251 |
| Jul 12, 2021 | GE Healthcare, LLC Discovery MR750 3.0T - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. Open, Classified |
LNH | K142085 K160618 +1 |
| Jul 12, 2021 | GE Healthcare, LLC Discovery MR750w 3.0T - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. Open, Classified |
LNH | K142085 K160618 +1 |
| Jul 12, 2021 | GE Healthcare, LLC SIGNA Pioneer - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. Open, Classified |
LNH | K143345 K153003 +1 |
| Jul 12, 2021 | GE Healthcare, LLC SIGNA Architect - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. Open, Classified |
LNH | K160618 K163331 +1 |
| Jul 12, 2021 | GE Healthcare, LLC SIGNA Premier - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. Open, Classified |
LNH | K171128 K183231 +1 |
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