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

Company	510(k)s	Recalls
Philips North America	0	236
Siemens Medical Solutions	136	61
GE Medical Systems	82	80
GE Healthcare	5	123
Hitachi Medical Systems America, Inc.	54	23
Philips Medical Systems Nederlands B.V.	3	67
Toshiba America Mri, Inc.	62	0
Philips Medical Systems (Cleveland), Inc.	57	4
Philips Medical Systems Nederland B.V.	27	14
Medical Advances, Inc.	38	0

Date	Firm and product	Code	Linked 510(k)
Aug 24, 2004	Siemens Medical Solutions USA, Inc Magnetom Sonata MRI System, Model 7106425 Terminated	LNH	K993731
Aug 24, 2004	Siemens Medical Solutions USA, Inc Magnetom Sonata MRI System, Model 7104719 Terminated	LNH	K993731
Aug 24, 2004	Siemens Medical Solutions USA, Inc Magnetom Sonata MRI System, Model 7388148 Terminated	LNH	K993731
Aug 24, 2004	Siemens Medical Solutions USA, Inc Magnetom Symphony MRI System, Model 7104594 Terminated	LNH	K971684
Aug 24, 2004	Siemens Medical Solutions USA, Inc Magnetom Symphony MRI System, Model 7106557 Terminated	LNH	K971684
Aug 24, 2004	Siemens Medical Solutions USA, Inc Magnetom Harmony MRI System Model number 5751438 Terminated	LNH	K970852
Aug 24, 2004	Siemens Medical Solutions USA, Inc Magnetom Harmony MRI System Model number 7106714 Terminated	LNH	K970852
Aug 24, 2004	Siemens Medical Solutions USA, Inc Magnetom Avanto MRI System, Model 7391167 Terminated	LNH	K032428
Jul 20, 2004	Philips Medical Systems Sales & Service Region No. America Trolley for Intera/NT MRI System Terminated	LNH	None listed
Jul 20, 2004	Toshiba American Med Sys Inc Magnetic Resonance Imaging System(s) Visart and Exelart P2/ Exelart P3/ Exelart SPIN and Exelart VANTAGE Terminated	LNH	K002531 K023511 +2
Jul 20, 2004	Toshiba American Med Sys Inc Magnetic Resonance Imaging System Core Software, Software installed in all of the following: Flexart MRI System, Visart MRI System, Exelart / Exelart P2 / Exelart P3 SPIN & Exelart VANTAGE MRI Syst Terminated	LNH	K002531 K933018 +3
Jul 20, 2004	USA Instruments Inc. Prima III TotalSENSE Torso Coil (Body Array Coil), labeled as Manufactured by: USA Instruments, Inc. This device is a component of the Magnetom TRIO 3.0T MRI Systems, manufactured by Siemens AG Medic Terminated	LNH	K030371
Jul 20, 2004	Toshiba American Med Sys Inc Magnetic Resonance Imaging, System: Flexart, Visart and Excelart Models. Terminated	LNH	K933018 K961092 +1
Feb 10, 2004	Siemens Medical Solutions USA, Inc Magnetom Trio System. Nuclear Magnetic Resonance Imaging Diagnostic Device Terminated	LNH	K013586
Dec 3, 2003	Siemens Medical Solutions USA, Inc Magnetic Resonance Imaging. Brand names: Concerto, Concerto Upgrade, Syngo Harmony, Syngo Harmony 087S, Syngo Harmony Upgrade, Syngo Sonata, Syngo Sonata Upgrade, Syngo Symphony, Syngo Symphony Q, and Terminated	LNH	K020991
Sep 12, 2003	Philips Medical Systems Gyroscan Intera 1.0T & 1.5T Terminated	LNH	K932645
Sep 12, 2003	Philips Medical Systems Gyroscan NT-Intera Terminated	LNH	K932645
Sep 12, 2003	Philips Medical Systems Gyroscan ACS-NT with software versions R6x, R7x, R8x Terminated	LNH	K932645
Sep 12, 2003	Philips Medical Systems Gyroscan 1.5T Intera Terminated	LNH	None listed
Sep 12, 2003	Philips Medical Systems Gyroscan NT-Intera 1.5T Terminated	LNH	None listed
Sep 12, 2003	Philips Medical Systems Gyroscan ACS-NT system Terminated	LNH	K932645
Aug 7, 2003	Siemens Medical Solutions USA, Inc MR Systems Terminated	LNH	K003628 K020991
Jul 3, 2003	Siemens Medical Solutions USA, Inc Magnetom Symphony/Sonata, OR Table. Terminated	LNH	K012495

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