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INVIVO CORPORATION

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
10517861051786INVIVO CORPORATION1N2026-01-0112151 Research Pkwy Orlando FL US 32826
10560691000113495INVIVO CORPORATION1Y2020-04-253545 SW 47th Ave GAINESVILLE FL US 32608
30057226723005722672INVIVO CORPORATION1N2020-04-253600 SW 47th Avenue GAINESVILLE FL US 32608

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
12531929009126K993819QWH-300 WRIST ARRAY COILMOS1999-12-03
12531209117672K993776OBC-300 BREAST ARRAY COILMOS1999-12-03
12532052297929K993477HRW WRIST ARRAY COILMOS1999-11-01
12531144147427K993279QSC-085 SHOULDER ARRAY COILMOS1999-10-15
12531463302134K991366DAUM MRI/CONVENTIONAL BIOPSY KITKNW1999-06-25
12531531331477K990782DAUM NEUROGATE TROCARKNW1999-04-28
12531317606059K990278DAUM NEUROCUT NEUROBIOPSYNEEDLEKNW1999-03-30
12531456544812K983109MODEL 545G-64 PAHASED ARRAY MUSCULOSKELETAL FLEX COIL PACKAGE MODEL 543GE-64: PHASED ARRAY UPPER EXTRENITY FLEX COIL ANYMOS1998-10-06
12531028393830K981320DAUM BONE BIOPSY SETKNW1998-06-29
12531078556459K974631DAUM NEUROBIOPSY NEEDLEKNW1998-03-09
12291335432721K974581MILLENNIA 3500 SERIES MONITOR WITH ANTHESTHETIC AGENTDRT1998-10-28
12531203409319K974576DAUM BIOPSYGUNKNW1998-03-06
12531169685159K974575DAUM ASPIRATIONBIOPSY NEEDLEKNW1998-03-06
12531692845957K974574DAUM NEUROPUNCTURE NEEDLEKNW1998-03-06
12291471515454K974212AIRIS IILNH1998-02-09
12531870862141K970868MODEL HNC NEUROVASCULAR ARRAY COILMOS1997-06-06
12531629689683K970037TARGOGRIDLNH1997-03-12
12531021958305K964668MODELS EXL AND EXS EXTREMITY COIL SETMOS1997-02-18
12531837834990K963894SMARTGUIDEFCG1997-03-11
12531248330583K963794PUNCTURENEEDLEKNW1998-03-19
12531835427081K962615TUMORLOCALIZER MRIMIG1998-03-19
12531904209257K961525ARRAY OPEN BREAST COIL (MODEL OBC-63 PA)MOS1996-09-05
12531479819954K961366MODEL #QSC-200-4C AND QSC-165-4C ARRAY SHOULDER COILSLNH1996-07-03
12531076810569K961185DAUM BIOPSYNEEDLEFCG1996-04-30
12291632422696K955045OMNI-TRAK PATIENT MONITORING SYSTEMDPS1996-07-11
12531645051704K954190MODEL 580GE-64 QUADRATURE ABDOMINAL FLEX COILMOS1995-11-20
12531157441157K945778PHASED ARRAY SHOULDER COIL, QUADRATURE SHOULDER COILLNH1995-03-23
12531949046115K944331MODEL 528GE SERIESLNH1995-01-25
12531984169778K941025PHASED ARRAY BREAST COILLNH1994-06-08
12531299708266K934396QUADRATURE LOWER EXTREMITY COILLNH1993-11-24
12291372827714K864730INVIVO PULSE OXIMETER, MODEL 4500DQA1987-05-06
12291064711372K212227Philips MR Patient Care PortalMWI2021-09-30
12531498322000K193403UroNav SystemLLZ2019-12-27
12601498322000K193403UroNav SystemLLZ2019-12-27
12531945870490K192200DynaCADLLZ2019-10-09
12601945870490K192200DynaCADLLZ2019-10-09
12531612383257K182561UroNav (Version 3.0)LLZ2018-10-19
12601612383257K182561UroNav (Version 3.0)LLZ2018-10-19
12531307729184K162863dS Small Extremity 16CH 1.5T CoilMOS2016-11-07
12531460822658K162177dS FootAnkle I6CH 1.5T CoilMOS2016-09-14
12531317741599K1620011.5T and 3.0T 16 CH GE Shoulder CoilsMOS2016-08-31
12531705222435K153073UroNav (Version 2.0)LLZ2015-11-16
12601705222435K153073UroNav (Version 2.0)LLZ2015-11-16
12291089276312K152330Expression MR400 MRI Patient Monitoring SystemMWI2015-12-23
12601509585163K133030DYNACAD/PROSTATE INTERVENTIONAL (DYNALOC/PROSTATE)LLZ2014-01-22
12531509585163K133030DYNACAD/PROSTATE INTERVENTIONAL (DYNALOC/PROSTATE)LLZ2014-01-22
12291281016346K132359MRI PATIENT MONITORING SYSTEMMWI2013-08-30
12291206754884K131382EXPRESSION MR200 MRI PATIENT MONITORING SYSTEM, EXPRESSION IP5 INFORMATION PORTALMWI2013-07-15
12291843284536K124061MRI PATIENT MONITORING SYSTEM (MODEL 865214)MWI2013-02-22
12531493489590K123492DS ANTERIOR, DS BASE, DS HEAD-NECK, DS HEAD, FLEX (S,M,L)MOS2012-12-13
12532024631931K122897SENSE HEAD 16 MODEL 800647, SENSE SPINE 16 MODEL 800646; SENSE TORSO 16 MODEL 800645MOS2012-12-21
12531589215518K122646DS BREAST 16CH I/T 1.5T DS BREAST 16CH I/T 3.0TMOS2012-11-02
12531938202800K121517VERSAVUE ENTERPRISE SUITELLZ2012-07-20
12291224754906K121424EXPRESSION INFORMATION PORTALMWI2012-06-13
12531405302711K120122SENSE MSK S 8CH 1.5TMOS2012-02-10
12531971738300K112122VENUE 40IYN2011-09-23
12531756818955K1116731.5T AND 3T 8-CHANNEL MEDIUM GENERAL PURPOSE FLEX COILMOS2011-12-23
12291659591418K110151ACHIEVA R4 1.5T AND ACHIEVA R4 3.0TLNH2011-03-22
12291749387598K103700ESSENTIAL MRI PATIENT MONITORDQA2011-03-15
12531761568737K103274SENTINELLE ENDO COIL ARRAY FOR PELVIC IMAGINGMOS2011-08-18
12531512181921K1031491.5T 16-CHANNEL HAND-WRIST COILMOS2011-01-03
12291210442860K101571XPER INFORMATION MANAGEMENT AND FLEX CARDIO PHYSIOMONITORING SYSTEMSMWI2010-10-26
12531879456016K100113VANGUARD BREAST MRI AUXILIARY TABLE WITH 16 CHANNEL COIL ARRAY FOR GE 3T MRI SYSTEM, MODEL 4000451-51MOS2010-04-22
12531290155278K0938421.5T AND 3.0T GENERAL PURPOSE FLEX COILSMOS2010-03-05
12531448916407K0932841.0T 8-CHANNEL PANORAMA BREAST ARRAY COILMOS2010-02-01
12531806312348K0919021.5T 8-CHANNEL SMALL EXTREMITY COIL, MODEL 800494, 3.0T 8-CHANNEL SMALL EXTREMITY COIL, MODEL 800484MOS2009-08-21
12291249396038K090785MRI COMPATIBLE PATIENT MONITORING SYSTEM, MODEL 865214MWI2009-12-15
12531159520643K090223ICAD BREAST INTERVENTIONAL PLANNING SOFTWARE, MODEL D70024LLZ2009-03-31
12531170929886K082987HRK-63-16 KNEE ARRAY COIL, HRK-127-16 KNEE ARRAY COILMOS2008-11-06
12531614495644K082916HRB-127-32 HIGH RESOLUTION BRAIN COILMOS2008-10-15
12601689668615K081262DC NEUROLLZ2008-06-17
12531689668615K081262DC NEUROLLZ2008-06-17
12291301750714K080038VANTAGE TITAN, MODEL MRT-1504/S3LNH2008-01-22
12531900766916K072873LBS-63-16 BREAST ARRAY COILMOS2007-11-16
12291927912213K063559ACHIEVA, INTERA AND PANORAMA 1.0T, RELEASE 2.5LNH2007-01-04
12531592358289K062767CTL-63 AND CTL-128 SPINE ARRAY COILSMOS2006-10-13
12532018552049K062767CTL-63 AND CTL-128 SPINE ARRAY COILSMOS2006-10-13
12532010603680K061952CARDIOVASCULAR ARRAY COILS, MODELS CAC-63-16, CAC-63-32, CAC-123-32 AND CAC-127-16MOS2006-07-28
12291922940509K061573TRANSPAC III DISPOSABLE STRAIGHT PRESSURE TRANSDUCER AND KITDRS2006-09-19
12531917787028K060873VANGUARD MRI AUXILIARY PATIENT TABLE WITH 4 AND 8 CHANNEL COIL ARRAY FOR GE SIGNA SYSTEMSMOS2006-04-14
12602009400078K053610ABARISJAK2006-04-19
12532009400078K053610ABARISJAK2006-04-19
12292066640574K0534623160 MRI PATIENT MONITORING SYSTEMMWI2006-01-18
12531064108729K053017MODELS HRS-63-8 AND HRS-127-8 SHOULDER ARRAY COILSMOS2005-11-16
12531463389072K052704MODEL BBD BREAST IMMOBILIZATION AND BIOPSY DEVICEMOS2005-11-03
12531337614096K052497NEUROVASCULAR ARRAY COIL, MODEL NVA-127-16-AMOS2005-10-12
12531789434327K052023CADIMAS VERSION 1.0LNH2005-12-08
12531402451664K050622HRW-63-8 WRIST ARRAY COIL; HRW-127-8 WRIST ARRAY COILMOS2005-04-08
12531331191872K050621NVA-127-8-A NEUROVASCULAR ARRAY COILMOS2005-04-07
12531913997375K050514MODELS FAC-63 AND FAC-127 FOOT AND ANKLE COILSMOS2005-03-25
12291545369252K050399MRI COMPATIBLE PATIENT MONITORING SYSTEM, MODEL 3160MWI2005-08-26
12531520994682K050299HRK-123 KNEE ARRAY COILMOS2005-02-24
12531160861605K042103NVA-63-8-A AND NVA-63-16-A NEUROVASCULAR ARRAY COILMOS2004-08-16
12291445920044K041918INTEGRATED PATIENT MONITORING SYSTEMMWI2004-10-15
12291030704016K041602PANORAMA 1.0TLNH2004-07-26
12531192032033K041481MODEL BBC-127 BIOPSY BREAST COILMOS2004-07-19
12531008965298K041286DYNACAD V1.0LNH2004-07-21
12601008965298K041286DYNACAD V1.0LNH2004-07-21
12531766692440K041185TORSO ARRAY COIL, MODEL 558GE-64MOS2004-05-14
12291970146654K040915MAGNITUDE 3150M MRI PATIENT MONITOR, MODEL 3150MMWI2004-09-22
12532012522869K040349MODIFICATION TO HRW-127 WRIST ARRAY COILMOS2004-03-09
12531401825749K040348MODIFICATION TO HNC-127-INT NEUROVASCULAR ARRAY COILMOS2004-03-09
12531077916159K040288QSC-127-INT SHOULDER ARRAY COIL SETMOS2004-03-05
12291662744829K040195CALYSTO IMAGE IV-IMAGE AND INFORMATION MANAGEMENT SYSTEMLLZ2004-04-07
12531476071802K033567MODELS HRK-63-8 PMS AND HRK-127-8 KNEE ARRAY COILSMOS2003-11-25
12531228343887K033447CLIPLOC SOFT TISSUE MARKER 18G/100MM (4), /130MM (5 1/8), /150MM (6), MODELS 12370, 12372, 12376NEU2004-01-28
12531684179656K033152HAC-12 AND HAC-30 HEAD ARRAY COILMOS2003-10-10
12531883931775K033151KFA-12 KNEE, FOOT, AND ANKLE ARRAY COILMOS2003-10-10
12531039693064K032633HRK-63-8 KNEE ARRAY COILMOS2003-09-25
12532000003574K032576BIOPSY BREAST COIL, MODEL BBCMOS2003-10-23
12531172996922K032429QSC-127 SHOULDER ARRAY COIL SETMOS2003-08-21
12531281561493K024352HRH-127-8 HEAD ARRAY COIL FOR GE SIGNA 3T EXCITE MRI SYSTEMMOS2003-01-09
12531806307445K024209QWH-250-PAN WRIST ARRAY COILMOS2003-01-09
12531056460081K024208OBC-250-PAN BREAST ARRAY COILMOS2003-01-07
12601847618035K023130ELOQUENCE, INTEGRATED FUNCTIONAL IMAGING SYSTEMLNH2002-10-11
12531847618035K023130ELOQUENCE, INTEGRATED FUNCTIONAL IMAGING SYSTEMLNH2002-10-11
12531030030746K023084MODEL 472GE-128: QUADRATURE LOWER EXTREMITY COILMOS2002-12-16
12531946883250K022910QSC-63-INT SHOULDER ARRAY COIL SETMOS2002-10-03
12531576773221K022883HRK-63 KNEE ARRAY COILMOS2002-09-27
12531210100760K022588HRW-63-INT WRIST ARRAY COILMOS2002-09-04

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MOS722016-11-07
LNH162011-03-22
LLZ152019-12-27
MWI122021-09-30
KNW102001-03-22
DQA22011-03-15
JAK22006-04-19
FCG21997-03-11
IYN12011-09-23
DRS12006-09-19
NEU12004-01-28
ERL12002-12-03
DRT11998-10-28
MIG11998-03-19
DPS11996-07-11

PMN#

GUDID#