FDA.reportPublic FDA data

Zhengbin Xu

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30026193373002619337Zhengbin Xu1N2026-01-0122010 SE 51 Street Issaquah WA US 98029
30069851473006985147Zhengbin Xu1N2026-01-0122010 SE 51 Street Issaquah WA US 98029

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
863721432016443K991805ASPEN ULTRASOUND WITH FREESTYLE IMAGING OPTIONIYN1999-08-02
863721247820596K946179SIEMENS SONOLINE 4XXIYO1995-10-03
126231364014859K253487ACUSON Maple Diagnostic Ultrasound System; ACUSON Maple Select Diagnostic Ultrasound SystemIYN2025-11-17
863721364014859K253487ACUSON Maple Diagnostic Ultrasound System; ACUSON Maple Select Diagnostic Ultrasound SystemIYN2025-11-17
126231115295580K253457ACUSON Juniper Diagnostic Ultrasound System; ACUSON Juniper Select Diagnostic Ultrasound SystemIYN2025-11-13
863721115295580K253457ACUSON Juniper Diagnostic Ultrasound System; ACUSON Juniper Select Diagnostic Ultrasound SystemIYN2025-11-13
126231772254102K251481ACUSON Sequoia Diagnostic Ultrasound System; ACUSON Sequoia Select Diagnostic Ultrasound System; ACUSON Origin Diagnostic Ultrasound System; ACUSON Origin ICE Diagnostic Ultrasound SystemIYN2025-08-20
863721772254102K251481ACUSON Sequoia Diagnostic Ultrasound System; ACUSON Sequoia Select Diagnostic Ultrasound System; ACUSON Origin Diagnostic Ultrasound System; ACUSON Origin ICE Diagnostic Ultrasound SystemIYN2025-08-20
126231421595643K243299ACUSON Redwood Diagnostic Ultrasound SystemIYN2024-11-15
863721421595643K243299ACUSON Redwood Diagnostic Ultrasound SystemIYN2024-11-15
126231164816927K242523ACUSON Sequoia Diagnostic Ultrasound System; ACUSON Sequoia Select Diagnostic Ultrasound System; ACUSON Origin Diagnostic Ultrasound System; ACUSON Origin ICE Diagnostic Ultrasound SystemIYN2024-11-19
863721164816927K242523ACUSON Sequoia Diagnostic Ultrasound System; ACUSON Sequoia Select Diagnostic Ultrasound System; ACUSON Origin Diagnostic Ultrasound System; ACUSON Origin ICE Diagnostic Ultrasound SystemIYN2024-11-19
126231518194669K240704ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound System, ACUSON Origin Diagnostic Ultrasound System, ACUSON Origin ICE Diagnostic Ultrasound SystemIYN2024-07-22
863721518194669K240704ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound System, ACUSON Origin Diagnostic Ultrasound System, ACUSON Origin ICE Diagnostic Ultrasound SystemIYN2024-07-22
126231989968322K233613ACUSON SC2000 Diagnostic Ultrasound SystemIYO2024-06-12
863721989968322K233613ACUSON SC2000 Diagnostic Ultrasound SystemIYO2024-06-12
126232019828918K233610ACUSON P500 Ultrasound System; ACUSON P500 ICE Ultrasound SystemIYN2024-06-12
863722019828918K233610ACUSON P500 Ultrasound System; ACUSON P500 ICE Ultrasound SystemIYN2024-06-12
863721438149075K233270AcuNav Crystal Ultrasound CatheterOBJ2023-10-28
126231808357657K232617ACUSON Maple Diagnostic Ultrasound System, ACUSON Maple Select Diagnostic Ultrasound SystemIYN2023-09-26
863721808357657K232617ACUSON Maple Diagnostic Ultrasound System, ACUSON Maple Select Diagnostic Ultrasound SystemIYN2023-09-26
863721460171041K232145ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound System, ACUSON Origin Diagnostic Ultrasound SystemIYN2023-10-30
126231654039238K230207ACUSON Juniper Diagnostic Ultrasound System, ACUSON Juniper Select Diagnostic Ultrasound SystemIYN2023-02-13
863721654039238K230207ACUSON Juniper Diagnostic Ultrasound System, ACUSON Juniper Select Diagnostic Ultrasound SystemIYN2023-02-13
863721123276282K223735ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound SystemIYN2023-02-06
863721971852586K221500ACUSON Sequoia Diagnostic Ultrasound SystemIYN2022-06-14
126231276141559K221190ACUSON Juniper Diagnostic Ultrasound System and ACUSON Juniper Select Diagnostic Ultrasound SystemIYN2022-08-16
863721276141559K221190ACUSON Juniper Diagnostic Ultrasound System and ACUSON Juniper Select Diagnostic Ultrasound SystemIYN2022-08-16
126231272589527K213487ACUSON P500 Ultrasound SystemIYN2022-02-11
863721272589527K213487ACUSON P500 Ultrasound SystemIYN2022-02-11
863721972443696K212959ACUSON AcuNav Volume Intracardiac Echocardiography(ICE) CatheterOBJ2021-10-15
863721669674294K211859ACUSON Sequoia Diagnostic Ultrasound SystemIYN2021-07-20
863721910045629K211726Acuson SC2000 Diagnostic Ultrasound SystemIYO2021-11-05
126231359595568K210743ACUSON Redwood Diagnostic Ultrasound SystemIYN2021-04-01
863721359595568K210743ACUSON Redwood Diagnostic Ultrasound SystemIYN2021-04-01
863721084886042K203726ACUSON AcuNav Volume Intracardiac Echocardiography(ICE) CatheterOBJ2021-01-19
863722064792953K202683ACUSON Sequoia Diagnostic Ultrasound System, ACUSON SC2000 Diagnostic Ultrasound System, ACUSON Freestyle Diagnostic Ultrasound System,ACUSON S1000, S2000, S3000 Diagnostic Ultrasound Systems, ACUSON P200 Diagnostic Ultrasound System, ACUSON P500 Diagnostic Ultrasound System, ACUSON NX3, NX3 Elite Diagnostic Ultrasound SystemIYN2020-10-15
863721722524341K201462ACUSON Sequoia Diagnostic Ultrasound SystemIYN2020-06-24
126231992079978K201130ACUSON Juniper Diagnostic Ultrasound SystemIYN2020-05-26
863721992079978K201130ACUSON Juniper Diagnostic Ultrasound SystemIYN2020-05-26
863721265423820K200707ACUSON Sequoia Diagnostic Ultrasound SystemIYN2020-04-15
863721909159032K200585Acuson SC2000 Diagnostic Ultrasound SystemIYN2020-04-22
863721033825396K193257ACUSON Sequoia Diagnostic Ultrasound SystemIYN2020-01-31
126231376852748K192835ACUSON NX3 Diagnostic Ultrasound System / ACUSON NX3 Elite Diagnostic Ultrasound SystemIYN2019-10-22
863721376852748K192835ACUSON NX3 Diagnostic Ultrasound System / ACUSON NX3 Elite Diagnostic Ultrasound SystemIYN2019-10-22
126231609564133K191922ACUSON P200 Diagnostic Ultrasound SystemIYN2019-08-15
863721609564133K191922ACUSON P200 Diagnostic Ultrasound SystemIYN2019-08-15
863721641241512K181098ACUSON SC2000 Diagnostic Ultrasound SystemIYN2018-05-31
863721067673579K180067ACUSON X800 Diagnostic Ultrasound SystemIYN2018-02-07
126231245278162K180039ACUSON P600 Diagnostic Ultrasound SystemIYN2018-02-01
863721245278162K180039ACUSON P600 Diagnostic Ultrasound SystemIYN2018-02-01
126231500667144K173981ACUSON NX2 Diagnostic Ultrasound System, ACUSON NX2 Elite Diagnostic Ultrasound SystemIYN2018-02-02
863721500667144K173981ACUSON NX2 Diagnostic Ultrasound System, ACUSON NX2 Elite Diagnostic Ultrasound SystemIYN2018-02-02
126231718433479K173957ACUSON NX3 Diagnostic Ultrasound System; ACUSON NX3 ELITE Diagnostic Ultrasound SystemIYN2018-02-01
863721718433479K173957ACUSON NX3 Diagnostic Ultrasound System; ACUSON NX3 ELITE Diagnostic Ultrasound SystemIYN2018-02-01
863721352221985K173618ACUSON AcuNav Volume Intracardiac Echocardiography CatheterOBJ2017-12-19
126231879359727K172374ACUSON NX2 Diagnostic Ultrasound System, ACUSON NX2 Elite Diagnostic Ultrasound SystemIYN2017-08-15
863721879359727K172374ACUSON NX2 Diagnostic Ultrasound System, ACUSON NX2 Elite Diagnostic Ultrasound SystemIYN2017-08-15
863721895914409K172162ACUSON S3000 S2000 S1000 Diagnostic Ultrasound SystemsIYN2017-08-16
863721585852692K171766Acuson SC2000 Diagnostic Ultrasound SystemIYO2017-07-12
863721483312683K170992AcuNav V 10F Ultrasound CatheterOBJ2017-06-15
863721226304231K170315Acuson SC2000 Diagnostic Ultrasound SystemIYN2017-04-04
863721110679234K170263AcuNav Diagnostic Ultrasound Catheter 8F,10FOBJ2017-06-15
863722044106893K163635ACUSON S1000/S2000/S3000 Diagnostic Ultrasound SystemsIYN2017-01-12
863721969913600K163478AcuNav Volume ICE CatheterOBJ2017-02-09
126231772298924K163396ACUSON P500 Ultrasound SystemIYN2017-01-04
863721772298924K163396ACUSON P500 Ultrasound SystemIYN2017-01-04
863721233805466K162243ACUSON S1000 / S2000 / S3000 Diagnostic Ultrasound SystemIYN2016-09-06
863721552900005K162221ACUSON SC2000 Diagnostic Ultrasound SystemIYN2016-09-06
126231033023721K161787ACUSON NX2 Diagnostic Ultrasound SystemsIYN2016-07-28
863721033023721K161787ACUSON NX2 Diagnostic Ultrasound SystemsIYN2016-07-28
126231891207123K152469ACUSON NX3 Elite / NX3 Diagnostic Ultrasound SystemIYN2015-09-21
863721891207123K152469ACUSON NX3 Elite / NX3 Diagnostic Ultrasound SystemIYN2015-09-21
863721974510423K152369ACUSON S1000, S2000, S3000 Diagnostic Ultrasuond SystemIYN2015-10-06
126231138973913K150050ACUSON P500 Diagnostic Ultrasound SystemIYN2015-02-09
863721138973913K150050ACUSON P500 Diagnostic Ultrasound SystemIYN2015-02-09
863721398401399K142876ACUSON S1000/ S2000/ S3000 Diagnostic Ultrasound SystemsIYN2014-10-23
863721165667725K142628Acuson SC2000 Diagnostic Ultrasound SystemIYN2014-10-10
863721644391792K142395SC2000 and ACUSON X300 Diagnostic Ultrasound SystemsIYO2014-09-09
126231519969884K141846ACUSON X700 ULTRASOUND SYSTEM, ACUSON X600 ULTRASOUND SYSTEMIYN2014-08-07
863721519969884K141846ACUSON X700 ULTRASOUND SYSTEM, ACUSON X600 ULTRASOUND SYSTEMIYN2014-08-07
863721333031080K140959ACUSON S1000, S2000, S3000 DIAGNOSTIC ULTRASOUND SYSTEMSIYN2014-04-30
863721193284920K132804ACUSON S1000 / S2000 / S3000IYN2013-10-24
863721012029656K132654ACUSON SC2000 DIAGNOSTIC ULTRASOUND SYSTEMIYO2013-09-26
863721822186125K131164ACUSONIYN2013-12-24
863721527913964K130881ACUSON S2000 AND S3000IYN2013-10-11
863721928687934K130754ACUSON SC2000 DIAGNOSTIC ULTRASOUND SYSTEMIYN2013-03-25
863721274886649K130739ACUSON S2000 AND S3000 DIAGNOSTIC ULTRASOUND SYSTEMSIYN2013-06-06
863722028724196K130619ACUSON S1000 DIAGNOSTIC ULTRASOUND SYSTEMIYN2013-03-21
863721561043872K123622ACUSONIYN2012-12-05
126231874934370K123001ACUSON X700 DIAGNSTIC ULTRASOUND SYSTEMIYN2012-10-26
863721874934370K123001ACUSON X700 DIAGNSTIC ULTRASOUND SYSTEMIYN2012-10-26
863721220891046K122825ACUSONIYN2012-09-28
126232062948437K121699ACUSON X300 DIAGNOSTIC ULTRASOUND SYSTEM SONOVISTA X300 DIAGNOSTIC ULTRASOUND SYSTEMIYN2012-06-22
863722062948437K121699ACUSON X300 DIAGNOSTIC ULTRASOUND SYSTEM SONOVISTA X300 DIAGNOSTIC ULTRASOUND SYSTEMIYN2012-06-22
126232040343802K121646ACUSON X150 DIAGNOSTIC ULTRASOUND SYSTEM SONOVISTA X150 DIAGNOSTIC ULTRASOUND SYSTEMIYN2012-06-22
863722040343802K121646ACUSON X150 DIAGNOSTIC ULTRASOUND SYSTEM SONOVISTA X150 DIAGNOSTIC ULTRASOUND SYSTEMIYN2012-06-22
863721718145958K121138ACUSON S3000 DIAGNOSTIC ULTRASOUND SYSTEMIYN2012-05-17
863721150584619K113179ACUSON SC2000 DIAGNOSTIC ULTRASOUND SYSTEMIYN2011-12-07
863721364990035K112596ACUSON S2000 DIAGNOSTIC ULTRASOUND SYSTEMIYN2011-09-16
863722024277749K111674ACUSONIYN2011-06-30
863721439789944K102017SC2000 DIAGNOSTIC ULTRASOUND SYSTEMIYN2010-09-20
863721923859334K093812ACUSON S2000 DIAGNOSTIC ULTRASOUND SYSTEMIYN2010-03-03
126232051911529K093531ACUSON MODEL X300 DIAGNOSTIC ULTRASOUND SYSTEMIYN2009-12-01
863722051911529K093531ACUSON MODEL X300 DIAGNOSTIC ULTRASOUND SYSTEMIYN2009-12-01
863721553596138K091295APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM MODEL SSA-790A VERSION 4.0ITX2009-05-15
863721187064196K090334ACUSON S2000 DIAGNOSTIC ULTRASOUND SYSTEMIYN2009-02-20
126231308992638K090276ACUSON X300 DIAGNOSTIC ULTRASOUND SYSTEMDQO2009-02-19
863721308992638K090276ACUSON X300 DIAGNOSTIC ULTRASOUND SYSTEMDQO2009-02-19
863721620785368K083114ACUSON P50 ULTRASOUND SYSTEMIYN2009-03-31
863721841176310K082142ACUSON S2000 DIAGNOSTIC ULTRASOUND SYSTEMIYN2008-11-13
863721346888240K081808ACUNAV V ULTRASOUND CATHETEROBJ2008-09-26
863722014246782K081148SIEMENS ACUSON 2000 ULTRASOUND SYSTEM WITH ABVS TRANSDUCERIYO2008-12-22
126231437490746K081121MODIFICATION TO ACUSON X150 ULTRASOUND SYSTEMIYO2008-06-04
863721437490746K081121MODIFICATION TO ACUSON X150 ULTRASOUND SYSTEMIYO2008-06-04
126231334974920K080760ACUSON X300 ULTRASOUND SYSTEMIYN2008-04-25
863721334974920K080760ACUSON X300 ULTRASOUND SYSTEMIYN2008-04-25
863721398233279K072786ACUSON S2000 ULTRASOUND SYSTEMITX2007-11-13

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
IYN1192025-11-17
IYO152024-06-12
OBJ112023-10-28
ITX32009-05-15
DQO22009-02-19