FDA.reportPublic FDA data

Ondrea Bermudez

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
80438361000185293Ondrea Bermudez1N2026-01-013721 VALLEY CENTRE DR San Diego CA US 92130
30054035183005403518Ondrea Bermudez1N2026-01-013721 VALLEY CENTRE DR San Diego CA US 92130
30106564003010656400Ondrea Bermudez1N2026-01-013721 VALLEY CENTRE DR San Diego CA US 92130
30335272833033527283Ondrea Bermudez1N2026-01-013721 VALLEY CENTRE DR San Diego CA US 92130

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3331721177303896K991671HDI 5000 DIAGNOSTIC ULTRASOUND SYSTEMIYO1999-06-18
3331721326600785K990339SONOS 5500 IMAGING SYSTEM M2424A VERSION B.OIYN1999-02-18
3439421650545076K243862LVivo Software ApplicationQIH2025-03-17
3439421725203696K243331LVivo SeamlessQIH2025-03-06
3439422040312946K243235LVivo Software ApplicationQIH2025-03-03
3331721002933266K242670Lumify Diagnostic Ultrasound SystemIYN2025-05-08
3331722023505101K242519Lumify Diagnostic Ultrasound SystemIYN2025-05-15
2806701380672905K241659Ultrasound Workspace (UWS 6.0)QIH2025-02-10
3439421673926895K240769LVivo IQSQIH2024-05-24
3439421232217710K240553LVivo Software ApplicationQIH2024-10-04
3439421468267578K222970LVivo IQSQIH2023-02-01
2806701177659823K213544TOMTEC-ARENAQIH2022-01-06
3331721314722734K212777Collaboration LiveLLZ2021-09-24
3331721458250520K212704Philips EPIQ Diagnostic Ultrasound System, Philips Affiniti Diagnostic Ultrasound SystemIYN2021-09-24
3439421011214059K212466LVivo SeamlessQIH2021-12-09
3331721344587417K211597EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemIYN2021-09-08
3439422007609969K210053LVivo Software ApplicationQIH2021-02-05
3331721112735061K203406Lumify Diagnostic Ultrasound SystemIYN2021-02-23
3439421265188509K202546LVivo SeamlessQIH2020-09-29
3331721856288179K202216EPIQ Series Diagnostic Ultrasound SystemsIYN2020-09-02
3331721356270618K201665Collaboration LiveLLZ2020-09-15
2806701181615785K201632TOMTEC-ARENALLZ2020-08-14
3331721281850111K2013523D Auto LAALLZ2020-08-17
3331721738063504K201053PercuNav Image Fusion and Interventional NavigationJAK2020-05-14
3331721591389388K201012EPIQ Diagnostic Ultrasound System Series, Affiniti Diagnostic Ultrasound System Series, CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System, Lumify Diagnostic Ultrasound SystemIYN2020-05-01
3331721988380984K200974QLAB Advanced Quantification SoftwareQIH2020-06-03
3331722001696745K200603AAA ModelLLZ2020-09-20
3331721138288257K200304EPIQ Diagnostic Ultrasound SystemIYN2020-03-06
3439422005543164K200232LVivo Software ApplicationQIH2020-06-23
3331721193374191K200179Collaboration LiveLLZ2020-02-18
3331721207277983K192226Lumify Diagnostic Ultrasound SystemIYN2019-09-06
3331721701408985K191647QLAB Advanced Quantification SoftwareQIH2019-12-20
3331722000658651K190913QLAB Advanced Quantification Software 13LLZ2019-06-18
3331721987703575K182857EPIQ Diagnostic Ultrasound System, EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System, Affiniti 30 Diagnostic Ultrasound System, Affiniti 50 Diagnostic Ultrasound System, Affiniti 70 Diagnostic Ultrasound SystemIYN2018-11-09
3331721876290552K182529Xperius Ultrasound SystemIYN2018-10-23
3331721000785157K181485EPIQ , EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 50 and Affiniti 70 Diagnostic Ultrasound SystemIYN2018-07-27
3331721049533428K181264QLAB Advanced Quantification SoftwareLLZ2018-06-07
3331721992450528K172607Philips EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System, Affiniti 30 Diagnostic Ultrasound System, Affiniti 50 Diagnostic Ultrasound System, Affiniti 70 Diagnostic Ultrasound SystemIYN2017-10-04
3331721330096492K171314QLAB Advanced Quantification SoftwareLLZ2017-05-30
3331721734113842K170716PercuNav Image Fusion and Interventional NavigationJAK2017-04-21
3331721219284102K163120EPIQ 5 Diagnostic Ultrasound System; EPIQ 7 Diagnostic Ultrasound System; Affiniti 50 Diagnostic Ultrasound System; Affiniti 70 Diagnostic Ultrasound SystemIYN2017-01-10
3331721590997478K163020Xperius Ultrasound SystemIYN2016-11-16
3331721631876373K162549Lumify Ultrasound SystemIYN2016-10-03
3331721593249916K162329CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound SystemIYN2016-09-14
3439421927816653K161382LVivo Software ApplicationLLZ2016-07-28
3331721129451507K160807EPIQ 5 Diagnostic Ultrasound System, EPIQ 7Diagnostic Ultrasound System, Affiniti 50 Diagnostic Ultrasound System, Affiniti 70 Diagnostic Ultrasound SystemIYN2016-04-06
3331722014823904K153480ClearVue850 Diagnostic Ultrasound SystemIYN2015-12-16
3331721840830559K152899Philips Lumify Diagnostic Ultrasound SystemIYN2015-10-30
2806701758960621K150122TOMTEC-ARENA TTA2LLZ2015-02-13
3331721198315328K141369VISIQ DIAGNOSTIC ULTRA SOUND SYSTEMIYN2014-07-02
3331721064572468K140808Q-STATIONLLZ2014-04-17
3331721862524852K132304EPIQ DIAGNOSTIC ULTRASOUND SYSTEMIYN2013-08-21
3331721973525460K132087PERCUNAV SYSTEMJAK2013-07-24
3439421114150529K130779LVIVO EF SYSTEMLLZ2013-08-15
3331721036845910K130499IU22 DIAGNOSTIC ULTRASOUND SYSTEMIYN2013-06-18
3331721402797219K123754CX50 3.0 DIAGNOSTIC ULTRASOUND SYSTEMIYN2012-12-21
3331721763009886K120321CLEARVUE 350/550 DIAGNOSTIC ULTRASOUND SYSTEMIYN2012-02-17
3331721088883167K111513CX50 DIAGNOSTIC ULTRASOUND SYSTEMIYN2011-06-24
2806701447311808K110667IMAGE-ARENA AND IMAGE-ARENA APPLICATIONSLLZ2011-04-08
3331721458224401K093563IU22 ULTRASOUND SYSTEM AND TRANSDUCERSIYN2010-02-01
3331721832469756K091804CX50 VERSION 2.0 DIAGNOSTIC ULTRASOUND SYSTEM AND TRANSDUCERSITX2009-07-17
3331721984277776K081802CX50 DIAGNOSTIC ULTRASOUND SYSTEMITX2008-07-11
3331721889208799K081661HD15 DIAGNOSTIC ULTRASOUND SYSTEMIYN2008-06-24
3331722045870733K063580SONOACE X8 DIAGNOSTIC ULTRASOUND SYSTEMIYN2006-12-14
3331721747951354K062247HD11 DIAGNOSTIC ULTRASOUND SYSTEMIYN2006-08-18
3331721128747180K043535HD11 DIAGNOSTIC ULTRASOUND SYSTEMIYN2005-01-06
3331721084785695K042540PHILIPS IU22 ULTRASOUND SYSTEMIYO2004-10-04
3331721016203625K030455BORIS PLATFORM DIAGNOSTIC ULTRASOUND SYSTEMIYN2003-03-13
3331721207529504K014191M2540 DIAGNOSTIC ULTRASOUND SYSTEM, MODEL M2540IYN2002-01-07
1239881000785157
1239881016203625
1239881036845910
1239881088883167
1239881128747180
1239881129451507
1239881138288257
1239881207529504
1239881326600785
1239881402797219
1239881458224401
1239881465817488
1239881485816841
1239881496891241
1239881593249916
1239881655202194
1239881734786918
1239881747951354
1239881763009886
1239881832469756
1239881862524852
1239881889208799
1239881987703575
1239882014823904

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
IYN342025-05-15
QIH142025-03-17
LLZ142021-09-24
JAK32020-05-14
ITX22009-07-17
IYO22004-10-04