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

DateFirm and productCodeLinked 510(k)
Sep 2, 2008Resonance Technology Inc
Headset Model Number RTC-2K for use with the Serene Sound Digital MRI Compatible High Fidelity Stereo Sound System.
Terminated
LNHK994351
Aug 23, 2008Hitachi Medical Systems America Inc
Altaire MRI System Emergency Rundown Switch Unit (ERDU) is intended to provide the physician with physiological and clinical information obtained non-invasive and without the use of ionizing radiation
Terminated
LNHK002420
Mar 25, 2008Siemens Medical Solutions USA, Inc
Siemens Magnetom Sonata syngo, Model Number: 7104719, Siemens Medical Solutions USA, Malvern PA, 19355
Terminated
LNHK971684
Mar 25, 2008Siemens Medical Solutions USA, Inc
Siemens Magentom Symphony syngo Upgrade, Model Number: 7106557, Siemens Medical Solutions USA, Malvern PA, 19355
Terminated
LNHK970852
Mar 25, 2008Siemens Medical Solutions USA, Inc
Siemens Magnetom Symphony syngo, Model Number: 7104594, Siemens Medical Solutions USA, Malvern PA, 19355
Terminated
LNHK970852
Mar 25, 2008Siemens Medical Solutions USA, Inc
Siemens Magnetom Sonata syngo, Model Number: 7106425, Siemens Medical Solutions USA, Malvern PA, 19355
Terminated
LNHK971684
Mar 25, 2008Siemens Medical Solutions USA, Inc
Siemens Magentom Symphony, Model Number: 4760265, Siemens Medical Solutions USA, Malvern PA, 19355
Terminated
LNHK970852
Mar 25, 2008Siemens Medical Solutions USA, Inc
Siemens Magnetom Harmony sygno. Model Number: 7104693, Siemens Medical Solutions USA, Malvern PA, 19355
Terminated
LNHK970852
Mar 25, 2008Siemens Medical Solutions USA, Inc
Siemens Magnetom Harmony syngo. Model Number: 7106714, Siemens Medical Solutions USA, Malvern PA, 19355
Terminated
LNHK970852
Mar 25, 2008Siemens Medical Solutions USA, Inc
Siemens Magnetom Harmony Mobile MRI System. Model Number: 4759309, Siemens Medical Solutions USA, Malvern PA, 19355
Terminated
LNHK970852
Feb 5, 2008Siemens Medical Solutions USA, Inc
Magnetom Espree with Swiveling OR (Operating Room) Table, Magnetic Resonance Imaging System,Siemens Medical Solutions USA, Inc., Malvern, PA
Terminated
LNHK041112
Nov 7, 2007GE Healthcare
Signa MFO/I Magnetic Resonance System, Model Numbers : 2210339, 2262700, 2276937, 2282853, 2282860, 2282880, 2352129, 2388781, 5105123, 5113339, 2138300-32, 2189500-3, 2198999-4, 2259620-4, 2262700-2
Terminated
LNHK002611
Sep 26, 2007Hitachi Medical Systems America Inc
Altaire Shoulder Coil, an accessory to the Altaire MRI system. The shoulder coil is a two-channel, receive only coil that functions at 29.641 MHz band. It consists of a cable and a coil (imaging) bo
Terminated
LNHK002420
Jun 27, 2007Philips Medical Systems North America Co. Phillips
Panorama 1.0T MRI
Terminated
LNHK041602
Jun 27, 2007Philips Medical Systems North America Co. Phillips
Achieva MRI
Terminated
LNHK031815
Jun 27, 2007Philips Medical Systems North America Co. Phillips
Intera MRI
Terminated
LNHK001796
Jun 27, 2007Philips Medical Systems North America Co. Phillips
Gyroscan MRI
Terminated
LNHK945945
May 18, 2007GE Medical Systems LLC
GE Healthcare-Americas Signa 3.0T EXCITE Whole Body Magnetic Resonance System
Terminated
LNHK040444
Apr 26, 2007Siemens Medical Solutions USA, Inc
Magnetom Espree System with OR Table
Terminated
LNHK041112
Feb 15, 2007USA Instruments Incorporated
The recalled product is the Large grid biopsy plate, part #2414797. The biopsy plate is labeled in part: Large Grid Biopsy Plate, part 2414797, For Use with the Liberty 9000 8-Channel Breast Coil, USA
Terminated
LNHK041695
K052585
Feb 15, 2007USA Instruments Incorporated
The recalled product is the Disposable biopsy plate, part #U1-150131. The biopsy plate is labeled in part: Disposable Biopsy Plate, part U1-150131, For Use with the Liberty 9000 8-Channel Breast Coil,
Terminated
LNHK041695
K052585
Feb 15, 2007USA Instruments Incorporated
The recalled product is the Lateral biopsy plate, part #2414346. The biopsy plate is labeled in part: Lateral Biopsy Plate, part 2414346, For Use with the Liberty 9000 8-Channel Breast Coil, USA Instr
Terminated
LNHK041695
K052585
Feb 15, 2007USA Instruments Incorporated
The recalled product is the medial biopsy plate, part #2414342. The biopsy plate is labeled in part: Medial Biopsy Plate, part 2414342, For Use with the Liberty 9000 8-Channel Breast Coil, USA Instrum
Terminated
LNHK041695
K052585
Feb 15, 2007USA Instruments Incorporated
LATERAL BIOPSY PLATE - For use with the Liberty 9000, 8-Channel Breast Coil. The Lateral Biopsy plate is sent to customers in the following configurations: 1) The plate is purchased in sets of 5 as p
Terminated
LNHK041695
K052585
Nov 29, 2006Siemens Medical Solutions USA, Inc
Magnetom Trio TIM, magnetic resonance imaging
Terminated
LNHK050200
Nov 29, 2006Siemens Medical Solutions USA, Inc
Magnetom Trio magnetic resonance imaging
Terminated
LNHK050200
Oct 12, 2006Hitachi Medical Systems America Inc
MRP-7000 and AIRIS Magnetic Resonance Imaging Systems, Software Versions: V7.0A to V7.0J.
Terminated
LNHK911667
K945155
Jun 14, 2006Hitachi Medical Systems America Inc
Hitachi AIRIS II MRI System
Terminated
LNHK001334
K974212
Jun 10, 2006Hitachi Medical Systems America Inc
MRP-7000, AIRIS Magnetic Resonance Imaging Systems
Terminated
LNHK911667
K945155
Jun 10, 2006Hitachi Medical Systems America Inc
AIRIS II, Altaire Nuclear Magnetic Resonance Imaging Device Systems
Terminated
LNHK002420
K974212
Jun 10, 2006Hitachi Medical Systems America Inc
Hitachi Altaire Magnetic Resonance Imaging System
Terminated
LNHK002420
K022390
May 31, 2006Hitachi Medical Systems America Inc
Magnetic Resonance Imaging Device
Terminated
LNHK002420
K022390 +2
May 10, 2006GE Medical Systems, LLC
GE Signa Advantage nuclear magnetic resonance imaging system.
Terminated
LNHNone listed
Jan 24, 2006Hitachi Medical Systems America Inc
The AIRIS II MR System is an imaging device and is intended to provide the physician with physiological and clinical information, obtained non invasively and without the use of ionizing radiation. The
Terminated
LNHK974212
Jan 24, 2006Hitachi Medical Systems America Inc
The AIRIS MR System is an imaging device and is intended to provide the physician with physiological and clinical information, obtained non invasively and without the use of ionizing radiation. The MR
Terminated
LNHK945155
Jan 6, 2006Philips Medical Systems North America Co. Phillips
Gyroscan NT MRI System rev 4.x, 5.x, and 6.x software. System, Nuclear Magnetic Resonance imaging.
Terminated
LNHK940534
Dec 14, 2005Toshiba American Med Sys Inc
Toshiba Excelart VANTAGE Model MRT-1503, Magnetic Resonance Imaging Systems, Regulation Number 21 CPR 892.1000, Regulatory Class II, Product Code 90-LNH and was cleared with K032490
Terminated
LNHK032490
Nov 15, 2005Siemens Medical Solutions USA, Inc
Breast Biopsy Aiming Device. Magnetic Resonance Imaging System. Model number 5728735
Terminated
LNHK010773
Jul 13, 2005Toshiba American Med Sys Inc
Magnetic Resonance Imaging Systems; Visart, Excelart / Excelart P2 / Excelart P3 / Excelart SPIN & Excelart VANTAGE.
Terminated
LNHK002531
K961092 +2
Jun 14, 2005Hitachi Medical Systems America Inc
Hitachi AIRIS Elite Magnetic Resonance Imaging Device
Terminated
LNHK032232
Jun 14, 2005Hitachi Medical Systems America Inc
Hitachi AIRIS II Magnetic Resonance Imaging Device
Terminated
LNHK001334
K974212
Jun 14, 2005Hitachi Medical Systems America Inc
Hitachi Altaire Magnetic Resonance Imaging Device.
Terminated
LNHK002420
K022390
May 17, 2005Hitachi Medical Systems America Inc
Altaire, Magnetic Resonance Imaging Device.
Terminated
LNHK002420
K022390
May 3, 2005Hitachi Medical Systems America Inc
Altaire, Magnetic Resonance Imaging Device.
Terminated
LNHK002420
K022390
Dec 2, 2004Toshiba American Med Sys Inc
Magnetic Resonance Imaging Systems, under the following names: Visart Excelart Excelart P2 Excelart P3 Excelart SPIN
Terminated
LNHNone listed
Dec 2, 2004Philips Medical Systems (Cleveland) Inc
Intinion 1.5 T MRI Scanner.
Terminated
LNHK003853
K011296
Dec 2, 2004Toshiba American Med Sys Inc
Magnetic Resonance Imaging Systems under the following names: Visart Excelart Excelart P2 Excelart P3 Excelart SPIN Excelart VANTAGE
Terminated
LNHK002531
K023511 +3
Nov 2, 2004Toshiba American Med Sys Inc
Excelart (tm) VANTAGE P2 & P3, Magnetic Resonance Imaging System,
Terminated
LNHK032490
Aug 24, 2004Siemens Medical Solutions USA, Inc
Magnetom Trio MRI System, Model 7387074
Terminated
LNHK013586
Aug 24, 2004Siemens Medical Solutions USA, Inc
Magnetom Trio MRI System, Model 7106441
Terminated
LNHK013586

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