FDA.reportPublic FDA data

Shelly Pearce

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30051505803005150580Shelly Pearce1N2020-04-25685 East Middlefield Road, PO Box 7393 Mountain View CA US 94043

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
126191376852748K192835ACUSON NX3 Diagnostic Ultrasound System / ACUSON NX3 Elite Diagnostic Ultrasound SystemIYN2019-10-22
126191609564133K191922ACUSON P200 Diagnostic Ultrasound SystemIYN2019-08-15
126191245278162K180039ACUSON P600 Diagnostic Ultrasound SystemIYN2018-02-01
126191500667144K173981ACUSON NX2 Diagnostic Ultrasound System, ACUSON NX2 Elite Diagnostic Ultrasound SystemIYN2018-02-02
126191718433479K173957ACUSON NX3 Diagnostic Ultrasound System; ACUSON NX3 ELITE Diagnostic Ultrasound SystemIYN2018-02-01
126191879359727K172374ACUSON NX2 Diagnostic Ultrasound System, ACUSON NX2 Elite Diagnostic Ultrasound SystemIYN2017-08-15
126191226304231K170315Acuson SC2000 Diagnostic Ultrasound SystemIYN2017-04-04
126191772298924K163396ACUSON P500 Ultrasound SystemIYN2017-01-04
126191033023721K161787ACUSON NX2 Diagnostic Ultrasound SystemsIYN2016-07-28
126191891207123K152469ACUSON NX3 Elite / NX3 Diagnostic Ultrasound SystemIYN2015-09-21
126191138973913K150050ACUSON P500 Diagnostic Ultrasound SystemIYN2015-02-09
126191644391792K142395SC2000 and ACUSON X300 Diagnostic Ultrasound SystemsIYO2014-09-09
126191519969884K141846ACUSON X700 ULTRASOUND SYSTEM, ACUSON X600 ULTRASOUND SYSTEMIYN2014-08-07
126191874934370K123001ACUSON X700 DIAGNSTIC ULTRASOUND SYSTEMIYN2012-10-26
126192062948437K121699ACUSON X300 DIAGNOSTIC ULTRASOUND SYSTEM SONOVISTA X300 DIAGNOSTIC ULTRASOUND SYSTEMIYN2012-06-22
126192040343802K121646ACUSON X150 DIAGNOSTIC ULTRASOUND SYSTEM SONOVISTA X150 DIAGNOSTIC ULTRASOUND SYSTEMIYN2012-06-22
126192051911529K093531ACUSON MODEL X300 DIAGNOSTIC ULTRASOUND SYSTEMIYN2009-12-01
126191308992638K090276ACUSON X300 DIAGNOSTIC ULTRASOUND SYSTEMDQO2009-02-19
126191437490746K081121MODIFICATION TO ACUSON X150 ULTRASOUND SYSTEMIYO2008-06-04
126191334974920K080760ACUSON X300 ULTRASOUND SYSTEMIYN2008-04-25
126191695632092K072676ACUSON X300 ULTRASOUND SYSTEMIYO2007-12-18
126191343888359K071036MODIFICATION TO ACUSON X300 ULTRASOUND SYSTEMIYN2007-05-16
126191364555578K070576ACUSON X150 ULTRASOUND SYSTEMIYN2007-03-26
126191407014532K061946ACUSON X300 DIAGNOSTIC ULTRASOUND SYSTEMIYN2006-07-21
126191621271124K043016SONOLINE ORCHID DIAGNOSTIC ULTRASOUND SYSTEMIYN2004-11-16

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
IYN212019-10-22
IYO32014-09-09
DQO12009-02-19