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) |
|---|---|---|---|
| Sep 2, 2008 | Resonance Technology Inc Headset Model Number RTC-2K for use with the Serene Sound Digital MRI Compatible High Fidelity Stereo Sound System. Terminated |
LNH | K994351 |
| Aug 23, 2008 | Hitachi 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 |
LNH | K002420 |
| Mar 25, 2008 | Siemens Medical Solutions USA, Inc Siemens Magnetom Sonata syngo, Model Number: 7104719, Siemens Medical Solutions USA, Malvern PA, 19355 Terminated |
LNH | K971684 |
| Mar 25, 2008 | Siemens Medical Solutions USA, Inc Siemens Magentom Symphony syngo Upgrade, Model Number: 7106557, Siemens Medical Solutions USA, Malvern PA, 19355 Terminated |
LNH | K970852 |
| Mar 25, 2008 | Siemens Medical Solutions USA, Inc Siemens Magnetom Symphony syngo, Model Number: 7104594, Siemens Medical Solutions USA, Malvern PA, 19355 Terminated |
LNH | K970852 |
| Mar 25, 2008 | Siemens Medical Solutions USA, Inc Siemens Magnetom Sonata syngo, Model Number: 7106425, Siemens Medical Solutions USA, Malvern PA, 19355 Terminated |
LNH | K971684 |
| Mar 25, 2008 | Siemens Medical Solutions USA, Inc Siemens Magentom Symphony, Model Number: 4760265, Siemens Medical Solutions USA, Malvern PA, 19355 Terminated |
LNH | K970852 |
| Mar 25, 2008 | Siemens Medical Solutions USA, Inc Siemens Magnetom Harmony sygno. Model Number: 7104693, Siemens Medical Solutions USA, Malvern PA, 19355 Terminated |
LNH | K970852 |
| Mar 25, 2008 | Siemens Medical Solutions USA, Inc Siemens Magnetom Harmony syngo. Model Number: 7106714, Siemens Medical Solutions USA, Malvern PA, 19355 Terminated |
LNH | K970852 |
| Mar 25, 2008 | Siemens Medical Solutions USA, Inc Siemens Magnetom Harmony Mobile MRI System. Model Number: 4759309, Siemens Medical Solutions USA, Malvern PA, 19355 Terminated |
LNH | K970852 |
| Feb 5, 2008 | Siemens Medical Solutions USA, Inc Magnetom Espree with Swiveling OR (Operating Room) Table, Magnetic Resonance Imaging System,Siemens Medical Solutions USA, Inc., Malvern, PA Terminated |
LNH | K041112 |
| Nov 7, 2007 | GE 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 |
LNH | K002611 |
| Sep 26, 2007 | Hitachi 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 |
LNH | K002420 |
| Jun 27, 2007 | Philips Medical Systems North America Co. Phillips Panorama 1.0T MRI Terminated |
LNH | K041602 |
| Jun 27, 2007 | Philips Medical Systems North America Co. Phillips Achieva MRI Terminated |
LNH | K031815 |
| Jun 27, 2007 | Philips Medical Systems North America Co. Phillips Intera MRI Terminated |
LNH | K001796 |
| Jun 27, 2007 | Philips Medical Systems North America Co. Phillips Gyroscan MRI Terminated |
LNH | K945945 |
| May 18, 2007 | GE Medical Systems LLC GE Healthcare-Americas Signa 3.0T EXCITE Whole Body Magnetic Resonance System Terminated |
LNH | K040444 |
| Apr 26, 2007 | Siemens Medical Solutions USA, Inc Magnetom Espree System with OR Table Terminated |
LNH | K041112 |
| Feb 15, 2007 | USA 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 |
LNH | K041695 K052585 |
| Feb 15, 2007 | USA 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 |
LNH | K041695 K052585 |
| Feb 15, 2007 | USA 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 |
LNH | K041695 K052585 |
| Feb 15, 2007 | USA 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 |
LNH | K041695 K052585 |
| Feb 15, 2007 | USA 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 |
LNH | K041695 K052585 |
| Nov 29, 2006 | Siemens Medical Solutions USA, Inc Magnetom Trio TIM, magnetic resonance imaging Terminated |
LNH | K050200 |
| Nov 29, 2006 | Siemens Medical Solutions USA, Inc Magnetom Trio magnetic resonance imaging Terminated |
LNH | K050200 |
| Oct 12, 2006 | Hitachi Medical Systems America Inc MRP-7000 and AIRIS Magnetic Resonance Imaging Systems, Software Versions: V7.0A to V7.0J. Terminated |
LNH | K911667 K945155 |
| Jun 14, 2006 | Hitachi Medical Systems America Inc Hitachi AIRIS II MRI System Terminated |
LNH | K001334 K974212 |
| Jun 10, 2006 | Hitachi Medical Systems America Inc MRP-7000, AIRIS Magnetic Resonance Imaging Systems Terminated |
LNH | K911667 K945155 |
| Jun 10, 2006 | Hitachi Medical Systems America Inc AIRIS II, Altaire Nuclear Magnetic Resonance Imaging Device Systems Terminated |
LNH | K002420 K974212 |
| Jun 10, 2006 | Hitachi Medical Systems America Inc Hitachi Altaire Magnetic Resonance Imaging System Terminated |
LNH | K002420 K022390 |
| May 31, 2006 | Hitachi Medical Systems America Inc Magnetic Resonance Imaging Device Terminated |
LNH | K002420 K022390 +2 |
| May 10, 2006 | GE Medical Systems, LLC GE Signa Advantage nuclear magnetic resonance imaging system. Terminated |
LNH | None listed |
| Jan 24, 2006 | Hitachi 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 |
LNH | K974212 |
| Jan 24, 2006 | Hitachi 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 |
LNH | K945155 |
| Jan 6, 2006 | Philips 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 |
LNH | K940534 |
| Dec 14, 2005 | Toshiba 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 |
LNH | K032490 |
| Nov 15, 2005 | Siemens Medical Solutions USA, Inc Breast Biopsy Aiming Device. Magnetic Resonance Imaging System. Model number 5728735 Terminated |
LNH | K010773 |
| Jul 13, 2005 | Toshiba American Med Sys Inc Magnetic Resonance Imaging Systems;
Visart, Excelart / Excelart P2 / Excelart P3 / Excelart SPIN & Excelart VANTAGE. Terminated |
LNH | K002531 K961092 +2 |
| Jun 14, 2005 | Hitachi Medical Systems America Inc Hitachi AIRIS Elite Magnetic Resonance Imaging Device Terminated |
LNH | K032232 |
| Jun 14, 2005 | Hitachi Medical Systems America Inc Hitachi AIRIS II Magnetic Resonance Imaging Device Terminated |
LNH | K001334 K974212 |
| Jun 14, 2005 | Hitachi Medical Systems America Inc Hitachi Altaire Magnetic Resonance Imaging Device. Terminated |
LNH | K002420 K022390 |
| May 17, 2005 | Hitachi Medical Systems America Inc Altaire, Magnetic Resonance Imaging Device. Terminated |
LNH | K002420 K022390 |
| May 3, 2005 | Hitachi Medical Systems America Inc Altaire, Magnetic Resonance Imaging Device. Terminated |
LNH | K002420 K022390 |
| Dec 2, 2004 | Toshiba American Med Sys Inc Magnetic Resonance Imaging Systems, under the following names:
Visart
Excelart
Excelart P2
Excelart P3
Excelart SPIN Terminated |
LNH | None listed |
| Dec 2, 2004 | Philips Medical Systems (Cleveland) Inc Intinion 1.5 T MRI Scanner. Terminated |
LNH | K003853 K011296 |
| Dec 2, 2004 | Toshiba American Med Sys Inc Magnetic Resonance Imaging Systems under the following names:
Visart
Excelart
Excelart P2
Excelart P3
Excelart SPIN
Excelart VANTAGE Terminated |
LNH | K002531 K023511 +3 |
| Nov 2, 2004 | Toshiba American Med Sys Inc Excelart (tm) VANTAGE P2 & P3, Magnetic Resonance Imaging System, Terminated |
LNH | K032490 |
| Aug 24, 2004 | Siemens Medical Solutions USA, Inc Magnetom Trio MRI System, Model 7387074 Terminated |
LNH | K013586 |
| Aug 24, 2004 | Siemens Medical Solutions USA, Inc Magnetom Trio MRI System, Model 7106441 Terminated |
LNH | K013586 |
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