FDA 510(k) Applications Submitted by INVIVO CORPORATION

FDA 510(k) Number Submission Date Device Name Applicant
K213766 12/01/2021 dS FootAnkle 16Ch Coils for 1.5T and 3.0T, dS HiRes HandWrist 16Ch Coils for 1.5T and 3.0T, ds Small Extremity 16Ch Coils for 1.5T and 3.0T Invivo Corporation
K111673 06/15/2011 1.5T AND 3T 8-CHANNEL MEDIUM GENERAL PURPOSE FLEX COIL INVIVO CORPORATION
K093284 10/20/2009 1.0T 8-CHANNEL PANORAMA BREAST ARRAY COIL INVIVO CORPORATION
K103149 10/25/2010 1.5T 16-CHANNEL HAND-WRIST COIL INVIVO CORPORATION
K093842 12/15/2009 1.5T AND 3.0T GENERAL PURPOSE FLEX COILS INVIVO CORPORATION
K162001 07/20/2016 1.5T and 3.0T 16 CH GE Shoulder Coils INVIVO CORPORATION
K162177 08/04/2016 dS FootAnkle I6CH 1.5T Coil Invivo Corporation
K153073 10/22/2015 UroNav (Version 2.0) INVIVO CORPORATION
K182561 09/18/2018 UroNav (Version 3.0) Invivo Corporation
K192200 08/13/2019 DynaCAD Invivo Corporation
K193403 12/06/2019 UroNav System Invivo Corporation
K122897 09/21/2012 SENSE HEAD 16 MODEL 800647, SENSE SPINE 16 MODEL 800646; SENSE TORSO 16 MODEL 800645 INVIVO CORPORATION
K120122 01/17/2012 SENSE MSK S 8CH 1.5T INVIVO CORPORATION
K122646 08/30/2012 DS BREAST 16CH I/T 1.5T DS BREAST 16CH I/T 3.0T INVIVO CORPORATION
K133030 09/26/2013 DYNACAD/PROSTATE INTERVENTIONAL (DYNALOC/PROSTATE) INVIVO CORPORATION
K212175 07/12/2021 DynaCAD Invivo Corporation
K061675 06/14/2006 VISION VXC CENTRAL STATION, MODEL 4300 INVIVO CORPORATION
K212227 07/16/2021 Philips MR Patient Care Portal Invivo Corporation
K053462 12/13/2005 3160 MRI PATIENT MONITORING SYSTEM INVIVO CORPORATION
K121424 05/14/2012 EXPRESSION INFORMATION PORTAL INVIVO CORPORATION
K131382 05/14/2013 EXPRESSION MR200 MRI PATIENT MONITORING SYSTEM, EXPRESSION IP5 INFORMATION PORTAL INVIVO CORPORATION
K062144 07/27/2006 ESCORT M8 VITAL SIGNS PATIENT MONITOR, MODEL 3810 INVIVO CORPORATION
K132359 07/30/2013 MRI PATIENT MONITORING SYSTEM INVIVO CORPORATION
K152330 08/18/2015 Expression MR400 MRI Patient Monitoring System INVIVO CORPORATION
K103700 12/20/2010 ESSENTIAL MRI PATIENT MONITOR INVIVO CORPORATION
K124061 12/31/2012 MRI PATIENT MONITORING SYSTEM (MODEL 865214) INVIVO CORPORATION
K081262 05/05/2008 DC NEURO INVIVO CORPORATION
K062767 09/15/2006 CTL-63 AND CTL-128 SPINE ARRAY COILS INVIVO CORPORATION
K053017 10/26/2005 MODELS HRS-63-8 AND HRS-127-8 SHOULDER ARRAY COILS INVIVO CORPORATION


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