FDA.report

Tracey Holevas

FDA Registration(s)

RegistrationFEINameStatusInitial importerExpiration yearAddress
80200213004377820Tracey Holevas1N2026-01-013000 N. Grandview BLVD Waukesha WI US 53188
96113431000284313Tracey Holevas1N2026-01-013000 N. Grandview BLVD Waukesha WI US 53188
96132993004571294Tracey Holevas1N2026-01-013000 N. Grandview BLVD Waukesha WI US 53188
96134453002175190Tracey Holevas1N2026-01-013000 N. Grandview BLVD Waukesha WI US 53188
96158493002973981Tracey Holevas1N2026-01-013000 N. Grandview BLVD Waukesha WI US 53188
96177663002874382Tracey Holevas1N2026-01-013000 N. Grandview BLVD Waukesha WI US 53188
97100903003208270Tracey Holevas1N2026-01-013000 N. Grandview BLVD Waukesha WI US 53188
30035944493003594449Tracey Holevas1N2026-01-013000 N. Grandview BLVD Waukesha WI US 53188
30087295473008729547Tracey Holevas1N2026-01-013000 N. Grandview BLVD Waukesha WI US 53188
30273389633027338963Tracey Holevas1N2026-01-013000 N. Grandview BLVD Waukesha WI US 53188
30328074643032807464Tracey Holevas1N2026-01-013000 N. Grandview BLVD Waukesha WI US 53188
30335082923033508292Tracey Holevas1N2026-01-013000 N. Grandview BLVD Waukesha WI US 53188
30335242513033524251Tracey Holevas1N2026-01-013000 N. Grandview BLVD Waukesha WI US 53188
30063404243006340424Tracey Holevas1N2020-04-253000 N. Grandview Blvd. Waukesha WI US 53188

Registered Device Listings

Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
266091978166529P990066GE HEALTHCARE SENOGRAPHE FULL FIELD DIGITAL MAMMOGRAPHY SYSTEMMUE2000-01-28
266091264430228P130020SENOCLAIREOTE2014-08-26
266691280000002K994167CODE AC: ATTENUATION CORRECTION SYSTEM FOR DUAL-HEAD VARIABLE-ANGLE GAMMA CAMERA WITH COINCIDENCE OPTION (CODE)KPS2000-03-07
266091008773360K993792SMART VESSEL ANALYSIS (SMART VA) OPTIONJAK1999-11-24
1224001323320976K993751COROMETRICS MODEL 173 FETAL MONITORHGM2000-02-02
266111375092983K993645CT/E COMPUTED TOMOGRAPHY SCANNNER SYSTEMJAK1999-12-21
266111078857097K993090SILHOUETTE FCKPR1999-10-01
266091541735498K993037LCV+ VERSION 2OWB2000-02-14
1224001165177655K991905COROMETRICS MODEL 171 AND 172 FETAL MONITORHGM1999-09-01
266691217983840K991896MG ATC: ATTENUATION CORRECTION SYSTEM FOR DUAL-HEAD VARIABLE-ANGLE GAMMA CAMERAKPS1999-08-23
3174971217983840K991896MG ATC: ATTENUATION CORRECTION SYSTEM FOR DUAL-HEAD VARIABLE-ANGLE GAMMA CAMERAKPS1999-08-23
266691671971920K991841HAWKEYE OPTION FOR DUAL-HEAD VARIABLE ANGLE GAMMA CAMERAKPS1999-08-26
266111963176997K982955SILHOUETTE VRKPR1998-11-04
266091107760443K981641MAMMOGRAPHY X-RAY EQUIPMENT MODELS MGF101 AND MGF110, ALPHA III, ALPHA ST, ALPHA RT AND ALPHA IQIZH1998-07-17
266691959257878K981352VPC-94 ULTRA HIGH ENERGY COLLIMATERS MODEL NUMBERS 480-685-9402KPS1998-07-13
266691571508207K980959VTRANSACT: ATTENUATION CORRECTION SYSTEM FOR DUAL-HEAD VARIABLE ANGLE GAMMA CAMERAKPS1998-06-04
266091978948086K974715ADVANTAGE 3D XRJAK1998-07-06
266091613657426K974367ADVANTX LCN, ADVANTX LCLPIZI1998-02-13
266091441648745K973270LEG'MAP OPTIONIZI1997-11-25
266691014793229K962738MILLENNIUM MT AND MILLENNIUM MG NUCLEAR MEDICINE SYSTEMSKPS1996-10-10
3174971014793229K962738MILLENNIUM MT AND MILLENNIUM MG NUCLEAR MEDICINE SYSTEMSKPS1996-10-10
266691900946764K962100VOLMETRIC COINCIDENCE DETECTION SYSTEMKPS1997-01-10
266091904429670K960575ADVANTX LCV+IZI1996-05-07
266691047873095K953801VARICAMKPS1995-11-22
266091910189716K953250SENOGRAPHE PEARL AND SENOGRAPHE SAPPHIREIZH1996-01-26
266691903785707K952674TRANSACT: ATTENUATION CORRECTION SYSTEM FOR THE APEX CARDIAL GAMMA CAMERAKPS1995-09-26
266691414492008K951144PHOENIX PLUS & BASE NUCLEAR MEDICINE SINGLE DETECTOR SYSTEMSKPS1995-07-03
3174971414492008K951144PHOENIX PLUS & BASE NUCLEAR MEDICINE SINGLE DETECTOR SYSTEMSKPS1995-07-03
266092048014015K945459DLXIZI1995-01-30
266091069726086K945375ADVANTX LCAIZI1995-01-30
266111480893543K944013CT PROSPEED FAMILYJAK1995-02-07
266691615791043K942837DST-XLKPS1995-01-05
266091653142839K941946LCA ANGIOGRAPHIC IMAGING SYSTEMIZI1994-05-20
266092073387123K941191REAL TIME STEREOTIXIZH1995-05-11
266092066580090K934478ALPHA STEREOIZH1995-01-31
266691290320814K932673APEX SPX CARDIALIYX1994-02-18
266091327129490K926258DLXIZI1993-03-15
266091378884894K923077ADVANTAGE WINDOWS 3D OPTION AND DENTASCAN OPTIONJAK1993-02-02
266691201105972K914807APEX HELIX - AKPS1992-02-27
266091635187547K913418SENOGRAPHE DMR/SMR/DMIZH1992-01-06
266091404518852K905653ADVANTX AFM ANGIO SYSTEM S1808IZI1991-05-15
266091033308024K894142ULTRANET-S COLLIMATORIZW1989-11-06
266091781010367K890348LC, CARDIAC POSITIONER #B5078AIZI1989-02-27
266692024609831K884675APEX 609R ANGER CAMERAIYX1989-04-17
266691148964187K884674APEX 415 ANGER CAMERAIYX1989-04-17
266092037858453K883664LUM VASCULAR PROCEDURE SYSTEM #B5200AIYB1988-11-07
266091590071536K881882SENOGRAPHE 600T AND 600TS SENIX HFIZH1988-05-25
266091543606929K873618STEREOTIXIZH1987-11-16
266091326004974K791830L/U ARM - NEURO - VASCULAR #B5080BJAA1979-10-26
266091636669634K781571L/U ARM-VASCULARIYB1978-11-27
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
266681228006311K260673LOGIQ 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
266091068435184K260087Senographe Pristina; SenoBright HD; Pristina Serena; Pristina Serena BrightMUE2026-03-24
266111119048953K253686True Definition DLJAK2026-03-23
266161695495357K253370LOGIQ TotusIYN2026-01-08
266261695495357K253370LOGIQ TotusIYN2026-01-08
266681695495357K253370LOGIQ TotusIYN2026-01-08
266161684322365K253366LOGIQ FortisIYN2026-01-07
266261684322365K253366LOGIQ FortisIYN2026-01-07
266681684322365K253366LOGIQ FortisIYN2026-01-07
266111041606167K253269OEC One CFDOXO2025-11-26
266261111491994K252328Voluson Expert 18; Voluson Expert 20; Voluson Expert 22IYN2025-11-24
266681111491994K252328Voluson Expert 18; Voluson Expert 20; Voluson Expert 22IYN2025-11-24
266162053695773K251985LOGIQ E10IYN2025-10-29
266262053695773K251985LOGIQ E10IYN2025-10-29
266682053695773K251985LOGIQ E10IYN2025-10-29
266161078030117K251963LOGIQ E10sIYN2025-10-29
266261078030117K251963LOGIQ E10sIYN2025-10-29
266681078030117K251963LOGIQ E10sIYN2025-10-29
1224001015150144K251670MAC 7 Resting ECG Analysis SystemDPS2026-01-26
1224001967523526K251663Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1)FMZ2025-10-22
266681146383654K251342EchoPAC Software Only / EchoPAC Plug-inQIH2025-07-16
3328431146383654K251342EchoPAC Software Only / EchoPAC Plug-inQIH2025-07-16
3328451146383654K251342EchoPAC Software Only / EchoPAC Plug-inQIH2025-07-16
266171846202890K251322Venue; Venue Go; Venue Fit; Venue SprintIYN2025-07-25
266261846202890K251322Venue; Venue Go; Venue Fit; Venue SprintIYN2025-07-25
266681846202890K251322Venue; Venue Go; Venue Fit; Venue SprintIYN2025-07-25
1224001846202890K251322Venue; Venue Go; Venue Fit; Venue SprintIYN2025-07-25
266091230809737K251199Allia MoveoOWB2025-12-09
266261040314840K251169Vivid PioneerIYN2025-07-10
266681040314840K251169Vivid PioneerIYN2025-07-10
3328431040314840K251169Vivid PioneerIYN2025-07-10
3328451040314840K251169Vivid PioneerIYN2025-07-10
266111410923542K251153AuroraKPS2025-06-12
266691410923542K251153AuroraKPS2025-06-12
3174971410923542K251153AuroraKPS2025-06-12
3329531410923542K251153AuroraKPS2025-06-12
266111652607470K250941Revolution VibeJAK2025-08-01
266111110546406K250788Definium Tempo SelectKPR2025-08-28
266161833596315K250543Voluson™ Performance 16; Voluson™ Performance 18IYN2025-05-29
266261833596315K250543Voluson™ Performance 16; Voluson™ Performance 18IYN2025-05-29
266681833596315K250543Voluson™ Performance 16; Voluson™ Performance 18IYN2025-05-29
266681495978933K250087Vscan AirIYN2025-05-01
1224001495978933K250087Vscan AirIYN2025-05-01
3328431495978933K250087Vscan AirIYN2025-05-01
3328451495978933K250087Vscan AirIYN2025-05-01
266091943732179K243672CardIQ SuiteJAK2025-06-18
266091168164462K243651VersaViewerLLZ2025-04-21
266261273874788K243628Vivid T9/Vivid T8IYN2025-02-11
266261905736941K243620Vivid iqIYN2025-02-11
266111409357724K243605AuroraKPS2025-01-17
266691409357724K243605AuroraKPS2025-01-17
3174971409357724K243605AuroraKPS2025-01-17
3329531409357724K243605AuroraKPS2025-01-17
266091611970213K2434463DXROWB2025-02-25
266112046382696K242678Definium Pace Select ETKPR2024-10-01
1224001257674419K242562Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125PMHX2025-07-09
266261519616603K242168Voluson Expert 18; Voluson Expert 20; Voluson Expert 22IYN2024-12-20
266681519616603K242168Voluson Expert 18; Voluson Expert 20; Voluson Expert 22IYN2024-12-20
266261955831828K242005Versana Premier; Versana Premier Lotus; LOGIQ FIYN2024-10-02
266681955831828K242005Versana Premier; Versana Premier Lotus; LOGIQ FIYN2024-10-02
266111201360968K241665Omni LegendKPS2024-08-08
266691201360968K241665Omni LegendKPS2024-08-08
3174971201360968K241665Omni LegendKPS2024-08-08
266691634743929K241350Clarify DLLLZ2025-01-03
3174971634743929K241350Clarify DLLLZ2025-01-03
266111974901503K240828OEC One ASDOXO2024-12-27
266171369655905K240206Venue SprintIYN2024-06-10
1224001369655905K240206Venue SprintIYN2024-06-10
266171829127751K240111VenueIYN2024-06-10

Product Codes Associated With Registrations

Product codeRegistration listing recordsLatest decision
IYN3442026-03-24
KPS902025-06-12
JAK712026-03-23
LLZ592025-04-21
MHX292025-07-09
OWB232025-12-09
MUE142026-03-24
LNH132016-08-31
DPS122026-01-26
IZI122011-12-13
KPR112025-08-28
IZH102004-04-19
IYO92012-04-19
ITX82020-11-20
OXO72025-11-26
MWI72024-04-25
FMT72022-03-02
IYX72016-11-18
FMZ62025-10-22
QIH52025-07-16
OSP52014-08-27
HGM42023-12-08
DQK32023-12-13
KPQ32014-03-14
DQA32010-03-12
IZL22016-11-15
DXJ22016-09-15
DXQ22013-04-09
IYB21988-11-07
OTE12014-08-26
IZF12013-11-18
MQB12010-11-18
BTL12007-04-20
BTM12007-04-20
DSI12007-03-16
OEB12004-11-18
DPZ12004-09-02
MOS12004-07-26
IZW11989-11-06
JAA11979-10-26