FDA.reportPublic FDA data

Tracey Holevas

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
96113431000284313Tracey Holevas1N2027-01-013000 N. Grandview BLVD Waukesha WI US 53188
96122833002808529Tracey Holevas1N2027-01-013000 N. Grandview BLVD Waukesha WI US 53188
96134453002175190Tracey Holevas1N2027-01-013000 N. Grandview BLVD Waukesha WI US 53188
96160473003377038Tracey Holevas1N2027-01-013000 N. Grandview BLVD Waukesha WI US 53188
96172773003190524Tracey Holevas1N2027-01-013000 N. Grandview BLVD Waukesha WI US 53188
30035944493003594449Tracey Holevas1N2027-01-013000 N. Grandview BLVD Waukesha WI US 53188
30071203363007120336Tracey Holevas1N2027-01-013000 N. Grandview BLVD Waukesha WI US 53188
30087295473008729547Tracey Holevas1N2027-01-013000 N. Grandview BLVD Waukesha WI US 53188
30150602243015060224Tracey Holevas1N2027-01-013000 N. Grandview BLVD Waukesha WI US 53188
30273389633027338963Tracey Holevas1N2027-01-013000 N. Grandview BLVD Waukesha WI US 53188
30328074643032807464Tracey Holevas1N2027-01-013000 N. Grandview BLVD Waukesha WI US 53188
30335082923033508292Tracey Holevas1N2027-01-013000 N. Grandview BLVD Waukesha WI US 53188
30063404243006340424Tracey Holevas1N2020-04-253000 N. Grandview Blvd. Waukesha WI US 53188

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
266091978166529P990066GE HEALTHCARE SENOGRAPHE FULL FIELD DIGITAL MAMMOGRAPHY SYSTEMMUE2000-01-28
266142013178386P870025FETAL ACOUSTIC STIMULATOR, MODEL 0146AAYMCP1988-08-31
266091264430228P130020SENOCLAIREOTE2014-08-26
266091008773360K993792SMART VESSEL ANALYSIS (SMART VA) OPTIONJAK1999-11-24
266141323320976K993751COROMETRICS MODEL 173 FETAL MONITORHGM2000-02-02
1224001323320976K993751COROMETRICS MODEL 173 FETAL MONITORHGM2000-02-02
266111375092983K993645CT/E COMPUTED TOMOGRAPHY SCANNNER SYSTEMJAK1999-12-21
266111078857097K993090SILHOUETTE FCKPR1999-10-01
266091541735498K993037LCV+ VERSION 2OWB2000-02-14
266141165177655K991905COROMETRICS MODEL 171 AND 172 FETAL MONITORHGM1999-09-01
1224001165177655K991905COROMETRICS MODEL 171 AND 172 FETAL MONITORHGM1999-09-01
3174971217983840K991896MG ATC: ATTENUATION CORRECTION SYSTEM FOR DUAL-HEAD VARIABLE-ANGLE GAMMA CAMERAKPS1999-08-23
266142061004286K991735MAC SERIES ELECTROCARDIOGRAPHS INCLUDING MAC 5000, MAC PC, MAC 6, MAC VU, MAC 8 ELECTROCARDIOGRAPHSLOS1999-08-19
266051994938556K991716HISPEED NX/I CT SCANNER SYSTEMJAK1999-06-18
266111963176997K982955SILHOUETTE VRKPR1998-11-04
266141676178048K982651COROMETRICS MODEL 5700 AND 2264 WATERTIGHT TRANSDUCERHEL1998-12-11
266032055471170K982267DPX-RX BONE DENSITOMETERKGI1998-08-18
266091107760443K981641MAMMOGRAPHY X-RAY EQUIPMENT MODELS MGF101 AND MGF110, ALPHA III, ALPHA ST, ALPHA RT AND ALPHA IQIZH1998-07-17
266051667739365K980176HISPEED QX/I CT SCANNER SYSTEMJAK1998-04-13
266051288921104K980169HISPEED LX//I, HISPEED FX/I, AND HISPEED DX/I FAMILY OF SYSTEMSJAK1998-04-13
266091978948086K974715ADVANTAGE 3D XRJAK1998-07-06
266091613657426K974367ADVANTX LCN, ADVANTX LCLPIZI1998-02-13
266141018349888K973403CARDIOSMART STLOS1998-03-12
266091441648745K973270LEG'MAP OPTIONIZI1997-11-25
266051147122009K963896MOBILE CT PROSPEED FAMILYJAK1996-12-18
3174971014793229K962738MILLENNIUM MT AND MILLENNIUM MG NUCLEAR MEDICINE SYSTEMSKPS1996-10-10
266091904429670K960575ADVANTX LCV+IZI1996-05-07
266091910189716K953250SENOGRAPHE PEARL AND SENOGRAPHE SAPPHIREIZH1996-01-26
3174971414492008K951144PHOENIX PLUS & BASE NUCLEAR MEDICINE SINGLE DETECTOR SYSTEMSKPS1995-07-03
266092048014015K945459DLXIZI1995-01-30
266091069726086K945375ADVANTX LCAIZI1995-01-30
266111480893543K944013CT PROSPEED FAMILYJAK1995-02-07
266091653142839K941946LCA ANGIOGRAPHIC IMAGING SYSTEMIZI1994-05-20
266092073387123K941191REAL TIME STEREOTIXIZH1995-05-11
266092066580090K934478ALPHA STEREOIZH1995-01-31
266091327129490K926258DLXIZI1993-03-15
266091378884894K923077ADVANTAGE WINDOWS 3D OPTION AND DENTASCAN OPTIONJAK1993-02-02
266051812425088K921192CT SYTEC 6000 COMPUTED TOMOGRAPHY SYSTEMJAK1992-10-20
266051686113718K913485CT SYTEC 8000JAK1992-01-23
266091635187547K913418SENOGRAPHE DMR/SMR/DMIZH1992-01-06
266051254576328K911387CT SYTEC 4000JAK1991-05-09
266141019514726K910260COROMETRICS MDL 330 FETAL/MATERNAL TELEMETRY SYSTHGM1991-03-15
266091404518852K905653ADVANTX AFM ANGIO SYSTEM S1808IZI1991-05-15
266091033308024K894142ULTRANET-S COLLIMATORIZW1989-11-06
266051717034491K893820CT SYTEC 3000JAK1989-08-07
266091781010367K890348LC, CARDIAC POSITIONER #B5078AIZI1989-02-27
266092037858453K883664LUM VASCULAR PROCEDURE SYSTEM #B5200AIYB1988-11-07
266051532268600K882581CT MAX 640 #B7940 JA/JEJAK1988-08-15
266091590071536K881882SENOGRAPHE 600T AND 600TS SENIX HFIZH1988-05-25
266091543606929K873618STEREOTIXIZH1987-11-16
266051861477927K872526CT PACE CATALOG NUMBER B7950AJAK1987-09-23
266051508641653K862317CT MAX, CATALOG NO. B7940 HAJAK1986-10-07
266051474458767K843927CT 9000JAK1984-12-17
266091326004974K791830L/U ARM - NEURO - VASCULAR #B5080BJAA1979-10-26
266091636669634K781571L/U ARM-VASCULARIYB1978-11-27
266141407356560K261933Voluson Expert 18; Voluson Expert 20; Voluson Expert 22IYN2026-10-02
266051407356560K261933Voluson Expert 18; Voluson Expert 20; Voluson Expert 22IYN2026-10-02
266261407356560K261933Voluson Expert 18; Voluson Expert 20; Voluson Expert 22IYN2026-10-02
266261913849570K261835LOGIQ FocusIYN2026-07-30
266051913849570K261835LOGIQ FocusIYN2026-07-30
266141913849570K261835LOGIQ FocusIYN2026-07-30
266051217580435K261668Venue GoIYN2026-08-07
1224001217580435K261668Venue GoIYN2026-08-07
266261217580435K261668Venue GoIYN2026-08-07
266141217580435K261668Venue GoIYN2026-08-07
3328451273808789K261623EchoPAC Software Only / EchoPAC Plug-in (v211)QIH2026-09-16
3328431273808789K261623EchoPAC Software Only / EchoPAC Plug-in (v211)QIH2026-09-16
266261928398916K261313Vivid Explorer/Vivid Advanced/Vivid FocusIYN2026-09-02
266141928398916K261313Vivid Explorer/Vivid Advanced/Vivid FocusIYN2026-09-02
266051928398916K261313Vivid Explorer/Vivid Advanced/Vivid FocusIYN2026-09-02
266051228006311K260673LOGIQ Vita; LOGIQ Vita Pro; LOGIQ Vita Express; LOGIQ Vita Plus; LOGIQ Vita Power; LOGIQ S20; LOGIQ S20 Pro; LOGIQ S20 Express; LOGIQ S20 Plus; LOGIQ S20 PowerIYN2026-03-24
266261228006311K260673LOGIQ Vita; LOGIQ Vita Pro; LOGIQ Vita Express; LOGIQ Vita Plus; LOGIQ Vita Power; LOGIQ S20; LOGIQ S20 Pro; LOGIQ S20 Express; LOGIQ S20 Plus; LOGIQ S20 PowerIYN2026-03-24
266141228006311K260673LOGIQ Vita; LOGIQ Vita Pro; LOGIQ Vita Express; LOGIQ Vita Plus; LOGIQ Vita Power; LOGIQ S20; LOGIQ S20 Pro; LOGIQ S20 Express; LOGIQ S20 Plus; LOGIQ S20 PowerIYN2026-03-24
266052053786010K260398LOGIQ eIYN2026-05-26
266142053786010K260398LOGIQ eIYN2026-05-26
266262053786010K260398LOGIQ eIYN2026-05-26
1224002053786010K260398LOGIQ eIYN2026-05-26
1224001006226786K260326Giraffe™ OmniBed™ Carestation (CS1); Giraffe™ Incubator Carestation (CS1)FMZ2026-07-28
266091068435184K260087Senographe Pristina; SenoBright HD; Pristina Serena; Pristina Serena BrightMUE2026-03-24
1224001964448704K254036Novii+ Wireless Patch SystemHGM2026-08-10
266091274636868K253770CardIQ SuiteJAK2026-07-21
266051119048953K253686True Definition DLJAK2026-03-23
266111119048953K253686True Definition DLJAK2026-03-23
266031480009403K253502Critical Care Suite with Enteric Tube Positioning AI AlgorithmQIH2026-04-14
266051695495357K253370LOGIQ TotusIYN2026-01-08
266261695495357K253370LOGIQ TotusIYN2026-01-08
266261684322365K253366LOGIQ FortisIYN2026-01-07
266051684322365K253366LOGIQ FortisIYN2026-01-07
266141684322365K253366LOGIQ FortisIYN2026-01-07
1224001379081908K253277Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125PMHX2026-07-24
266111041606167K253269OEC One CFDOXO2025-11-26
266111692648950K252718Lunar AstraKGI2026-04-20
266031692648950K252718Lunar AstraKGI2026-04-20
266141111491994K252328Voluson Expert 18; Voluson Expert 20; Voluson Expert 22IYN2025-11-24
266261111491994K252328Voluson Expert 18; Voluson Expert 20; Voluson Expert 22IYN2025-11-24
266051111491994K252328Voluson Expert 18; Voluson Expert 20; Voluson Expert 22IYN2025-11-24
266052053695773K251985LOGIQ E10IYN2025-10-29
266142053695773K251985LOGIQ E10IYN2025-10-29
266262053695773K251985LOGIQ E10IYN2025-10-29
266141078030117K251963LOGIQ E10sIYN2025-10-29
266051078030117K251963LOGIQ E10sIYN2025-10-29
266261078030117K251963LOGIQ E10sIYN2025-10-29
1224001015150144K251670MAC 7 Resting ECG Analysis SystemDPS2026-01-26
1224001967523526K251663Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1)FMZ2025-10-22
3328451146383654K251342EchoPAC Software Only / EchoPAC Plug-inQIH2025-07-16
3328431146383654K251342EchoPAC Software Only / EchoPAC Plug-inQIH2025-07-16
266051846202890K251322Venue; Venue Go; Venue Fit; Venue SprintIYN2025-07-25
266141846202890K251322Venue; Venue Go; Venue Fit; Venue SprintIYN2025-07-25
1224001846202890K251322Venue; Venue Go; Venue Fit; Venue SprintIYN2025-07-25
266261846202890K251322Venue; Venue Go; Venue Fit; Venue SprintIYN2025-07-25
266091230809737K251199Allia MoveoOWB2025-12-09
266051040314840K251169Vivid PioneerIYN2025-07-10
266141040314840K251169Vivid PioneerIYN2025-07-10
266261040314840K251169Vivid PioneerIYN2025-07-10
3328451040314840K251169Vivid PioneerIYN2025-07-10
3328431040314840K251169Vivid PioneerIYN2025-07-10
3174971410923542K251153AuroraKPS2025-06-12
266111410923542K251153AuroraKPS2025-06-12
266111652607470K250941Revolution VibeJAK2025-08-01
266111110546406K250788Definium Tempo SelectKPR2025-08-28

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
IYN4582026-10-02
JAK1062026-07-21
LLZ492025-04-21
KPS442025-06-12
MHX302026-07-24
LNH282023-10-27
OWB232025-12-09
DPS172026-01-26
IYO172012-04-19
MUE142026-03-24
KPR142025-08-28
HGM122026-08-10
IZI122011-12-13
IZH102004-04-19
ITX92020-11-20
QIH82026-09-16
FMT82022-03-02
FMZ72026-07-28
KGI72026-04-20
OXO72025-11-26
MWI72024-04-25
OSP52014-08-27
DQK32023-12-13
IZL32021-04-28
KPQ32014-03-14
DQA32010-03-12
IYX22016-11-18
DXJ22016-09-15
DXQ22013-04-09
LBI22012-05-02
MOS22011-03-07
LOS21999-08-19
IYB21988-11-07
QKB12025-04-01
QBS12023-05-25
QFM12019-08-12
OTE12014-08-26
IZF12013-11-18
MQB12010-11-18
BTL12007-04-20