FDA.reportPublic FDA data

INVIVO CORPORATION

Matched from indexed company URL: INVIVO CORP.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
10517861051786INVIVO CORPORATION1N2026-01-0112151 Research Pkwy Orlando FL US 32826
30141730603014173060Invivoscribe, Inc.1N2026-01-0110222 Barnes Canyon Road, Building 1 San Diego CA US 92121
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
2142181340000896P160040LeukoStrat CDx FLT3 Mutation AssayOWD2017-04-28
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
12531509585163K133030DYNACAD/PROSTATE INTERVENTIONAL (DYNALOC/PROSTATE)LLZ2014-01-22
12601509585163K133030DYNACAD/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
12531689668615K081262DC NEUROLLZ2008-06-17
12601689668615K081262DC 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
12532009400078K053610ABARISJAK2006-04-19
12602009400078K053610ABARISJAK2006-04-19
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
12531847618035K023130ELOQUENCE, INTEGRATED FUNCTIONAL IMAGING SYSTEMLNH2002-10-11
12601847618035K023130ELOQUENCE, 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

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
OWD12017-04-28
IYN12011-09-23
DRS12006-09-19
NEU12004-01-28
ERL12002-12-03
DRT11998-10-28
MIG11998-03-19
DPS11996-07-11

PMA#

LeukoStrat CDx FLT3 Mutation Assay

2022-04-11

INVIVOSCRIBE TECHNOLOGIES, INC10222 Barnes Canyon Road, Building 1san Diego, CA 92121 PMA NumberP160040 Supplement NumberS010 Date Received03/15/2022 Decision Date04/11/2022 Product Code OWD  Advisory Committee Pathology Supplement Type30-day Notice Supplem...

PMN#

8ch Wrist Coil

2022-08-31

Invivo Corporation (Business Trade Name: Philips)

DynaCAD

2021-08-02

Invivo Corporation

DynaCAD

2019-10-09

Invivo Corporation

63 records. Showing 1-40. Next

GUDID#

LeukoStrat - The LeukoStrat CDx FLT3 Mutation Assay targets regions of the FLT3 gene to identify internal tandem duplication (ITD) mutations and tyrosine kinase domain (TKD) mutations, such as the D835 and I836 mutations. The LeukoStrat CDx FLT3 Mutation Assay includes reagents, equipment, software and procedures for isolating mononuclear cells and extracting DNA from patient specimens to determine if FLT3 mutations are present. DNA is amplified via PCR, TKD amplicon is enzymatically digested, and the amplicons are detected via capillary electrophoresis.

INVIVOSCRIBE, INC.

2020-05-29

80 records. Showing 1-40. Next