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) |
|---|---|---|---|
| Aug 2, 2024 | GE Medical Systems, LLC 1.5T SIGNA HDxt Family, with affected software versions: HD16.0_V03 to HD16.4, HD23.0_V03, HD28.0, HD29.1, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System Open, Classified |
LNH | K052293 K121676 |
| Aug 2, 2024 | GE Medical Systems, LLC SIGNA Voyager, with affected software versions: PX26.0 to PX26.6, VX28.0, VX29.1, VX29.2, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System Open, Classified |
LNH | K143251 |
| Aug 2, 2024 | GE Medical Systems, LLC SIGNA Artist, with affected software versions: DV26.0, DV27.1, DV28.1, DV29.1, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System Open, Classified |
LNH | K160618 K163331 +1 |
| Aug 2, 2024 | GE Medical Systems, LLC Optima MR450w 1.5T, with affected software versions: DV24.0, DV25.0, DV25.1, DV26.0, DV29.1, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System Open, Classified |
LNH | K132376 K142085 +2 |
| Aug 2, 2024 | GE Medical Systems, LLC Discovery MR450 1.5T, with affected software versions: DV24.0, DV25.0, DV25.1, DV26.0; Nuclear Magnetic Resonance Imaging System Open, Classified |
LNH | K142085 K160618 +1 |
| Aug 2, 2024 | GE Medical Systems, LLC Discovery MR750w 3.0T, with affected software versions: DV24.0, DV25.0, DV25.1, DV26.0 to DV26.5, DV29.1, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System Open, Classified |
LNH | K142085 K160618 +1 |
| Aug 2, 2024 | GE Medical Systems, LLC Discovery MR750 3.0T, with affected software versions: DV24.0, DV25.0, DV25.1, DV26.0 to DV26.4, DV29.1, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System Open, Classified |
LNH | K142085 K160618 +1 |
| Aug 2, 2024 | GE Medical Systems, LLC 3.0T SIGNA HDxt Family, with affected software versions: RX27.0 to RX27.3, RX28.0, RX29.0 to RX29.2, MR30.0, MR30.1HD16.0_V03, HD23.0_V03; Nuclear Magnetic Resonance Imaging System Open, Classified |
LNH | K052293 K121676 |
| Aug 2, 2024 | GE Medical Systems, LLC SIGNA Premier, with affected software versions: RX27.0 to RX27.3, RX28.0, RX29.0 to RX29.2, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System Open, Classified |
LNH | K171128 K183231 +1 |
| Aug 2, 2024 | GE Medical Systems, LLC SIGNA Hero, with affected software versions: PX29.1, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System Open, Classified |
LNH | K213668 |
| Aug 2, 2024 | GE Medical Systems, LLC SIGNA Pioneer, with affected software versions: PX25.0 to PX25.5, PX26.0, PX26.1, PX28.0 to PX28.4, PX29.0, PX29.1, MR30.0, MR30.1; Nuclear Magnetic Resonance
Imaging System Open, Classified |
LNH | K143345 K153003 +1 |
| Aug 2, 2024 | GE Medical Systems, LLC SIGNA Architect, with affected software versions: DV26.0 to DV26.3, DV27.0 to DV27.3, DV28.0 to DV28.5, DV29.0, DV29.1, DV29.2, MR30.0, MR30.1; Nuclear Magnetic Resonance
Imaging System Open, Classified |
LNH | K160618 K163331 +1 |
| Jun 9, 2024 | Canon Medical System, USA, INC. MRI systems: Vantage Orian MRT-1550 (MEXL-1550), Vantage Elan MRT-2020 (MEXL-1520), Vantage Titan MRT-1504 (MEXL-1504), Vantage Titan 3T MRT-3010 (MEXL-3010), Vantage Galan 3T MRT-3020 (MEXL-3020) Open, Classified |
LNH | K122613 K191128 +3 |
| Jun 4, 2024 | Philips North America Llc HA FlexTrak II-Patient transport functionality to transport the patient from the preparation area to the MR system,
Product Number: 989710008732 Open, Classified |
LNH | K213583 |
| Jun 4, 2024 | Philips North America Llc HA FlexTrak-Patient transport functionality to transport the patient from the preparation area to the MR system,
Product Number: 989710006412 Open, Classified |
LNH | K213583 |
| Jun 4, 2024 | Philips North America Llc HA FlexTrak-Patient transport functionality to transport the patient from the preparation area to the MR system,
Product Number: 989710006411 Open, Classified |
LNH | K213583 |
| May 17, 2024 | Philips North America Llc Upgrade dStream - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device
Model Number (REF): 782127 Open, Classified |
LNH | None listed |
| May 17, 2024 | Philips North America Llc Sonalleve MR HIFU 3.0T - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device.
Model Number (REF): 781361 Open, Classified |
LNH | None listed |
| May 17, 2024 | Philips North America Llc SmartPath to Ingenia Elition X - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device.
Model Number (REF): 782118 Open, Classified |
LNH | None listed |
| May 17, 2024 | Philips North America Llc SmartPath to dStream for XR and 3.0T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device.
Model Number (REF):
(1) 782129;
(2) 782113;
(3) 78127 Open, Classified |
LNH | None listed |
| May 17, 2024 | Philips North America Llc SmartPath to dStream for 3.0T
Model Number (REF): 782145 Open, Classified |
LNH | None listed |
| May 17, 2024 | Philips North America Llc SmartPath to dStream for 1.5T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device.
Model Number (REF):
782146;
782112;
781260 Open, Classified |
LNH | None listed |
| May 17, 2024 | Philips North America Llc MR RT Upgrades- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device.
Model Number (REF): 781440 Open, Classified |
LNH | None listed |
| May 17, 2024 | Philips North America Llc MR RT - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device.
Model Number (REF): 781439 Open, Classified |
LNH | None listed |
| May 17, 2024 | Philips North America Llc MR system 1.5T Marlin- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device.
Model Number (REF): 781483 Open, Classified |
LNH | None listed |
| May 17, 2024 | Philips North America Llc Marlin 1.5T - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device.
Model Number (REF): 781474 Open, Classified |
LNH | None listed |
| May 17, 2024 | Philips North America Llc Panorama HFO- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device.
Model Number (REF): 781350 Open, Classified |
LNH | K063559 |
| May 17, 2024 | Philips North America Llc MR 5300- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device.
Model Number (REF):
(1) 782152
(2) 782110 Open, Classified |
LNH | K212673 |
| May 17, 2024 | Philips North America Llc Intera 1.5T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device.
Model Number (REF): 781295 Open, Classified |
LNH | K193215 |
| May 17, 2024 | Philips North America Llc Ingenia Elition X- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device.
Model Number (REF): 781358 Open, Classified |
LNH | K193215 |
| May 17, 2024 | Philips North America Llc Ingenia Ambition X- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device
Model Number (REF):
(1) 782138;
(2) 782109;
(3) 781356 Open, Classified |
LNH | K193215 K213583 |
| May 17, 2024 | Philips North America Llc Ingenia Ambition S
Model Number (REF):
(1) 782139;
(2) 782133;
(3) 782108;
(4) 781359 Open, Classified |
LNH | K193215 K213583 |
| May 17, 2024 | Philips North America Llc Ingenia 3.0T CX
Model Number (REF):
(1) 782105
(2) 781271 Open, Classified |
LNH | K193215 |
| May 17, 2024 | Philips North America Llc Ingenia 3.0T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device.
Model Number (REF):
(1) 782103
(2) 781377
(3) 781342 Open, Classified |
LNH | K193215 |
| May 17, 2024 | Philips North America Llc Ingenia 1.5T S
Model Number (REF):
781347 Open, Classified |
LNH | K193215 |
| May 17, 2024 | Philips North America Llc Ingenia 1.5T CX - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device.
Model Number (REF):
(1) 781262
(2) 781261 Open, Classified |
LNH | K193215 |
| May 17, 2024 | Philips North America Llc Ingenia 1.5T
Model Number (REF):
(1) 782140;
(2) 782115;
(3) 782101;
(4) 781396;
(5) 781341;
(6) 781315 Open, Classified |
LNH | K193215 |
| May 17, 2024 | Philips North America Llc Evolution upgrade 3.0T
Model Number (REF):
(1)782117;
(2) 782143 Open, Classified |
LNH | None listed |
| May 17, 2024 | Philips North America Llc Evolution upgrade 1.5T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device
Model Number (REF):
(1) 782116;
(2) 782148 Open, Classified |
LNH | None listed |
| May 17, 2024 | Philips North America Llc AchievaXR -Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device
Model Number (REF): 781253 Open, Classified |
LNH | K193215 |
| May 17, 2024 | Philips North America Llc Achieva 3.0T TX for PET
Model Number (REF): 781479 Open, Classified |
LNH | None listed |
| May 17, 2024 | Philips North America Llc Achieva 3.0T for PET -Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device
Model Number (REF): 781477 Open, Classified |
LNH | None listed |
| May 17, 2024 | Philips North America Llc Achieva 3.0T
Model Number (REF):
(1) 781345;
(2) 781344;
(3) 781278;
(4) 781277;
(5) 781177 Open, Classified |
LNH | K193215 |
| May 17, 2024 | Philips North America Llc Achieva 1.5T Initial system
Model Number (REF): 781178 Open, Classified |
LNH | K193215 |
| May 17, 2024 | Philips North America Llc Achieva 1.5T Conversion- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device
Model Number (REF):
(1) 781283;
(2) 781346 Open, Classified |
LNH | K193215 |
| May 17, 2024 | Philips North America Llc Achieva 1.5T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device
Model Number (REF):
(1) 781296
(2) 781343 Open, Classified |
LNH | K193215 |
| May 15, 2024 | Philips North America Llc Ingenia 3.0T with Evolution Upgrade 3.0T - - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device
REF: 782117 Open, Classified |
LNH | K193215 |
| May 15, 2024 | Philips North America Llc Ingenia 1.5T with Evolution Upgrade 1.5T - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device
REF: 782116 Open, Classified |
LNH | K193215 |
| Apr 17, 2024 | Philips North America Llc SmartPath to dStream for XR and 3.0T, Magnetic Resonance System. Open, Classified |
LNH | None listed |
| Apr 17, 2024 | Philips North America Llc SmartPath to dStream for 1.5T, Magnetic Resonance System. Open, Classified |
LNH | None listed |
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