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

Company510(k)sRecalls
Philips North America0236
Siemens Medical Solutions13661
GE Medical Systems8280
GE Healthcare5123
Hitachi Medical Systems America, Inc.5423
Philips Medical Systems Nederlands B.V.367
Toshiba America Mri, Inc.620
Philips Medical Systems (Cleveland), Inc.574
Philips Medical Systems Nederland B.V.2714
Medical Advances, Inc.380
DateFirm and productCodeLinked 510(k)
Nov 21, 2023Philips North America Llc
Intera 1.5T
Open, Classified		 LNHK052013
K052078 +3
Nov 21, 2023Philips North America Llc
Ingenia 1.5T CX
Open, Classified		 LNHK052013
K052078 +3
Nov 21, 2023Philips North America Llc
Achieva 1.5T Initial System
Open, Classified		 LNHNone listed
Nov 21, 2023Philips North America Llc
Achieva 1.5T Conversion
Open, Classified		 LNHK052013
K052078 +3
Nov 21, 2023Philips North America Llc
Achieva 1.5T
Open, Classified		 LNHK052013
K052078 +3
Sep 29, 2023Siemens Medical Solutions USA, Inc
(1) Over-ear headphones used with the MAGNETOM Amira MAGNETOM Free.Star MAGNETOM Sempra, MAGNETOM Free.Max, MAGNETOM Mica MAGNETOM Spectra Siemens Model Number:11060845 Used with the following MAGN
Open, Classified		 LNHK153447
K183221 +3
Aug 11, 2023Philips North America
MR 7700 Magnetic Resonance (MR) system, Product Numbers 782120 and 782130 (Upgrade to MR 7700)
Open, Classified		 LNHK213583
Aug 11, 2023Philips North America
Ingenia Elition S Magnetic Resonance (MR) system, Product Numbers 781357 and 782106
Open, Classified		 LNHK173356
K173451 +3
Aug 11, 2023Philips North America
Ingenia Elition X Magnetic Resonance (MR) system, Product Numbers 781358, 782107, and 782118 (SmartPath to Ingenia Elition X)
Open, Classified		 LNHK173356
K173451 +3
Aug 11, 2023Philips North America
MR 7700 Magnetic Resonance (MR) system, Product Numbers 782120 and 782130 (Upgrade to MR 7700)
Open, Classified		 LNHK213583
Aug 11, 2023Philips North America
Ingenia Elition S Magnetic Resonance (MR) system, Product Numbers 781357 and 782106
Open, Classified		 LNHK173356
K173451 +3
Aug 11, 2023Philips North America
Ingenia Elition X Magnetic Resonance (MR) system, Product Numbers 781358, 782107, and 782118 (SmartPath to Ingenia Elition X)
Open, Classified		 LNHK173356
K173451 +3
Dec 8, 2022Philips North America Llc
Philips Upgrade to MR 7700 System, Model Number 782130
Open, Classified		 LNHK173356
K173451 +3
Dec 8, 2022Philips North America Llc
Philips MR 7700 System, Model Number 782120
Open, Classified		 LNHK173356
K173451 +3
Dec 8, 2022Philips North America Llc
Philips SmartPath to Ingenia Elition X MR System, Model Numbers 782118, 782132, 782144
Open, Classified		 LNHK173356
K173451 +3
Dec 8, 2022Philips North America Llc
Philips Ingenia Elition X MR System, Model Numbers 781358, 782107, 782119, 782136
Open, Classified		 LNHK173356
K173451 +3
Dec 8, 2022Philips North America Llc
Philips Ingenia Elition S MR System, Model Numbers 781357, 782106, 782137
Open, Classified		 LNHK173356
K173451 +3
Jun 24, 2022GE Healthcare, LLC
SIGNA Premier magnetic resonance scanner, model 5748519.
Open, Classified		 LNHK171128
K183231 +1
Apr 21, 2022GE Healthcare, LLC
GE Healthcare MR Systems, Magnetic Resonance imaging (MRI). SIGNA Premier, SIGNA Architect, SIGNA Pioneer, Discovery MR750w 3.0T, Discovery MR750 3.0T, SIGNA PET/MR, 1.5T SIGNA Creator, 1.5T SIGNA
Open, Classified		 LNHK211980
Apr 4, 2022GE Healthcare, LLC
1.5T and 3.0T SIGNA HDx, 1.5T and 3.0T SIGNA HDxt, and 1.5T SIGNA HDxt Mobile. Magnetic Resonance Imaging System
Open, Classified		 LNHK052293
K121676
Apr 4, 2022GE Healthcare, LLC
SIGNA Excite 3T. Magnetic Resonance Imaging System
Open, Classified		 LNHNone listed
Apr 4, 2022GE Healthcare, LLC
1.5T SIGNA Excite HD, 3.0T SIGNA Excite HD. Magnetic Resonance Imaging System
Open, Classified		 LNHK041476
Apr 4, 2022GE Healthcare, LLC
Signa 1.5T TwinSpeed Magnetic Resonance Imaging System
Open, Classified		 LNHK012200
Dec 23, 2021GE Healthcare, LLC
GE Healthcare MR superconducting magnets, a component of GE Healthcare Orthone (1.0T MSK Extreme) System, nuclear magnetic resonance imaging system.
Open, Classified		 LNHK001773
Dec 23, 2021GE Healthcare, LLC
GE Healthcare MR superconducting magnets, a component of GE Healthcare Optima MR430s System, nuclear magnetic resonance imaging system.
Open, Classified		 LNHK103238
K123068
Dec 23, 2021GE Healthcare, LLC
GE Healthcare MR superconducting magnets, a component of GE Healthcare MR MAX System, nuclear magnetic resonance imaging system.
Open, Classified		 LNHK883547
K895794 +1
Dec 23, 2021GE Healthcare, LLC
GE Healthcare MR superconducting magnets, a component of GE Healthcare MR Vectra System, nuclear magnetic resonance imaging system.
Open, Classified		 LNHK913673
K921653 +1
Dec 23, 2021GE Healthcare, LLC
GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Horizon Cx System (sold under SIGNA Horizon Cx, SIGNA Horizon Lx, SIGNA Infinity, SIGNA MR/I, SmartSpeed, EchoSpeed Plus, a
Open, Classified		 LNHK962061
Dec 23, 2021GE Healthcare, LLC
GE Healthcare MR superconducting magnets, a component of GE Healthcare Contour System, nuclear magnetic resonance imaging system.
Open, Classified		 LNHK950973
K964370
Dec 23, 2021GE Healthcare, LLC
GE Healthcare MR superconducting magnets, a component of GE SIGNA Excite 1.5T MR System, GE SIGNA Excite 3.0T MR System, nuclear magnetic resonance imaging system.
Open, Classified		 LNHK041476
Dec 23, 2021GE Healthcare, LLC
GE Healthcare MR superconducting magnets, a component of GE SIGNA 3.0T with Excite MR System, nuclear magnetic resonance imaging system.
Open, Classified		 LNHK040444
Dec 23, 2021GE Healthcare, LLC
GE Healthcare MR superconducting magnets, a component of GE 3.0T SIGNA Infinity TwinSpeed with Excite MR System, nuclear magnetic resonance imaging system.
Open, Classified		 LNHK030874
Dec 23, 2021GE Healthcare, LLC
GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA 3.0T MR System, nuclear magnetic resonance imaging system.
Open, Classified		 LNHK022397
Dec 23, 2021GE Healthcare, LLC
GE Healthcare MR superconducting magnets, a component of GE Healthcare Brivo MR355 System, nuclear magnetic resonance imaging system.
Open, Classified		 LNHK120778
Dec 23, 2021GE Healthcare, LLC
GE Healthcare MR superconducting magnets, a component of GE Healthcare Brivo MR355/Optima MR360 System, nuclear magnetic resonance imaging system.
Open, Classified		 LNHK103330
K123417
Dec 23, 2021GE Healthcare, LLC
GE Healthcare MR superconducting magnets, a component of GE Healthcare 1.5T SIGNA HDe MR System, nuclear magnetic resonance imaging system.
Open, Classified		 LNHK052978
Dec 23, 2021GE Healthcare, LLC
GE Healthcare MR superconducting magnets, a component of GE 0.7T SIGNA OpenSpeed with Excite MR System, nuclear magnetic resonance imaging system.
Open, Classified		 LNHK032795
Dec 23, 2021GE Healthcare, LLC
GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA OpenSpeed MR System, nuclear magnetic resonance imaging system.
Open, Classified		 LNHK012875
Dec 23, 2021GE Healthcare, LLC
GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA HFO/I MR System, nuclear magnetic resonance imaging system.
Open, Classified		 LNHK992746
Dec 23, 2021GE Healthcare, LLC
GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Infinity MR System, SIGNA Infinity MR System with Excite Technology, nuclear magnetic resonance imaging system.
Open, Classified		 LNHK013636
Dec 23, 2021GE Healthcare, LLC
GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA 1.5T TwinSpeed MR System, nuclear magnetic resonance system.
Open, Classified		 LNHK012200
Dec 23, 2021GE Healthcare, LLC
GE Healthcare MR superconducting magnets, a component of GE 1.5T SIGNA HDx MR System, GE 3.0T SIGNA HDx MR System, GE 1.5T SIGNA HDxt MR System, GE 3.0T SIGNA HDxt MR System, 1.5T SIGNA HDxt, 3.0T SIG
Open, Classified		 LNHK052293
K121676
Dec 23, 2021GE Healthcare, LLC
GE Healthcare MR superconducting magnets, a component of GE Healthcare Discovery MR450 1.5T system, nuclear magnetic resonance imaging system.
Open, Classified		 LNHK132376
K142085 +2
Dec 23, 2021GE Healthcare, LLC
GE Healthcare MR superconducting magnets, a component of GE Healthcare Optima MR450w 1.5T, Optima MR450w GEM system, nuclear magnetic resonance imaging system.
Open, Classified		 LNHK132376
K142085 +1
Dec 23, 2021GE Healthcare, LLC
GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Artist system, nuclear magnetic resonance imaging system.
Open, Classified		 LNHK160618
K163331 +1
Dec 23, 2021GE Healthcare, LLC
GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Voyager and SIGNA Voyager Premier Edition system, nuclear magnetic resonance imaging system.
Open, Classified		 LNHK161567
K192426
Dec 23, 2021GE Healthcare, LLC
GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA MR380 System, nuclear magnetic resonance system.
Open, Classified		 LNHNone listed
Dec 23, 2021GE Healthcare, LLC
GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA MR355 and SIGNA MR360 System, nuclear magnetic resonance imaging system.
Open, Classified		 LNHK143251
Dec 23, 2021GE Healthcare, LLC
GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Creator and SIGNA Explorer System, nuclear magnetic resonance imaging system.
Open, Classified		 LNHK143251
Dec 23, 2021GE Healthcare, LLC
GE Healthcare MR superconducting magnets, a component of GE Healthcare Discovery MR750 3.0T System, nuclear magnetic resonance imaging system.
Open, Classified		 LNHK132376
K142085 +2

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