FDA.reportPublic FDA data

FUJIFILM SONOSITE,INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30323673002087856FUJIFILM SONOSITE,INC.1N2026-01-0121919 30th Dr SE BOTHELL WA US 98021

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1631691615620040K994096SONOHEART HAND-CARRIED ECHOCARDIOGRAPHY SYSTEMIYN1999-12-20
1631691838858351K990806C1 ULTRASOUND SYSTEMIYN1999-03-26
1631691071058980K981505COZUMEL DIAGNOSTIC ULTRASOUND SYSTEMIYO1998-05-08
1631691728685296K974725BIOZ.COM SYSTEMDSB1998-03-18
1631691591346241K972320BIOZ SYSTEM & BIOZ PORTABLEDSB1997-09-11
1631691304088981K253448Sonosite MT Ultrasound SystemIYN2025-11-03
1631691727641030K251830Sonosite LX Ultrasound SystemIYN2025-07-10
1631691220781925K251106Sonosite LX and Sonosite PX Ultrasound SystemsIYN2025-08-29
1631691531730196K233597Sonosite LX Ultrasound SystemIYN2023-12-06
1631691108700126K213763Sonosite PX Ultrasound SystemIYN2021-12-27
1631691968139254K200964Sonosite PX Ultrasound SystemIYN2020-05-08
1631691536826409K190476FUJIFILM Sonosite Vevo MD Imaging SystemIYN2019-03-15
1631691571034959K183235SonoSite SII Ultrasound SystemIYN2019-02-07
1631691553652158K180704SonoSite iViz Ultrasound SystemIYN2018-04-13
1631691437925549K171437SonoSite X-Porte Ultrasound SystemIYN2017-06-12
1631691575555244K162288SonoSite iViz Ultrasound SystemIYN2016-09-08
1631691385654955K162045SonoSite SII Ultrasound System, SonoSite Edge II Ultrasound SystemIYN2016-08-18
1631691831613796K161119SonoSite iViz Ultrasound SystemIYN2016-05-13
1631691304303830K160734SonoSite SII Ultrasound SystemIYN2016-04-05
1631691666851779K160674Fujifilm Sonosite Vevo MD Imaging SystemIYN2016-04-19
1631691979888110K160406FUJIFILM FC1 Ultrasound SystemIYN2016-03-16
1631691879435364K153626SonoSite Edge II Ultrasound SystemIYN2016-01-20
1631691403609329K152983FUJIFILM SonoSite iViz Ultrasound SystemIYN2015-11-12
1631691089522969K152209FUJIFILM SonoSite X-Porte Ultrasound SystemIYN2015-08-19
1631691124394314K142017X-PORTE ULTRASOUND SYSTEMIYN2014-08-22
1631691292764190K133454SONOSITE EDGE ULTRASOUND SYSTEMIYN2013-12-16
1631691436799859K133134X-PORTE ULTRASOUND SYSTEMIYN2013-11-04
1631691537629172K130173SONOSITE MAXX SERIES ULTRASOUND SYSTEMIYN2013-03-25
1631691299941633K113680SOMA ACCESS SYSTEMS EXACTTRACK PROCEDURE KITIYO2011-12-29
1631692018621245K113156SONOSITE EDGE ULTRASOUND SYSTEMIYO2011-11-15
1631691750976372K110645BIO Z CARDIO PROFILE HEMODYNAMIC MONITORDSB2011-06-03
1631691103963268K102390SONOSITE NANOMAXX SERIES ULTRASOUND SYSTEMIYN2010-11-19
1631692036245729K101757SONOSITE NANOMAXX SERIES ULTRASOUND SYSTEM, SONOSITE MAXX SERIES ULTRASOUND SYSTEMITX2010-08-12
1631691563660110K093510LUMENVU CATHETER GUIDANCE SYSTEMOMF2010-08-23
1631691653814404K092058SONOSITE NANOMAXX SERIES ULTRASOUND SYSTEMIYN2009-10-02
1631691582621946K090602CARDIODYNAMICS BIOZ RX, MODEL 7101-SYSDSB2009-05-28
1631691711180377K082098SONOSITE MAXX SERIES ULTRASOUND SYSTEMIYN2008-08-25
1631691575106625K071134SONOSITE MAXX SERIES DIAGNOSTIC ULTRASOUND SYSTEMIYO2007-05-08
1631691469704418K070156BIOZ DX HEMODYNAMIC MONITOR WITH PHILIPS 12-LEAD ECG, MODEL 5100DSB2007-09-26
1631691878856823K053069SONOSITE MICROMAXX DIAGNOSTIC ULTRASOUND SYSTEM (C3 SERIES)IYN2005-11-16
1631691655652509K052109SONOSITE HAND-CARRIED ULTRASOUND SYSTEM (C1 SERIES)IYN2005-08-11
1631691418926130K051228BIOZDX HEMODYNAMIC MONITOR AND 12-LEAD ECGDSB2005-06-10
1631691423894959K043559SONOSITE HIGH-RESOLUTION DIAGNOSTIC ULTRASOUND SYSTEM (C3 SERIES)IYN2005-01-12
1631691927570328K043452TITAN HIGH RESOLUTION ULTRASOUND SYSTEM AND SONOSITE ULTRASOUND SYSTEMIYN2004-12-21
1631691948776630K041294BIOZDX HEMODYNAMIC MONITORDSB2004-12-08
1631691686124739K033367TITAN ULTRASOUND SYSTEM, SONOSITE ILOOK 25 ULTRASOUND SYSTEM, 180PLUS ULTRASOUND SYSTEM, MODEL L03073, L02245, L02464IYN2003-11-05
1631691465348880K030949TITAN HIGH RESOLUTION ULTRASOUND SYSTEMIYN2003-04-07
1631692004458827K030064ILOOK 25 NEEDLE GUIDE ATTACHMENT AND BRACKET ASSEMBLYITX2003-01-22
1631691452231107K023957SONOSITE HAND-CARRIED ULTRASOUND SYSTEM (C2 SERIES)IYN2002-12-12
1631691358247110K021628SONOSITE HAND-CARIED UNTRASOUND SYSTEM (POWERSERIES)IYN2002-05-31
1631691977724275K014116HAND-CARRIED ULTRASOUND SYSTEMIYN2001-12-20
1631691110571033K011797BIOZTECT SENSOR AND BIOZTECT CABLEDSB2001-07-03
1631691037724774K011439MODIFICATION TO BIOZ.COM HEMODYNAMIC MONITORDSB2001-11-02
1631691857987317K010374SONOSITE HAND-CARRIED ULTRASOUND SYSTEMIYN2001-02-21
1631691447897123K003399SONOSITE HAND-CARRIED ULTRASOUND SYSTEMIYN2000-11-16
1631692067956865K001100BIOZ.COM HEMODYNAMIC MONITOR WITH BIOZ TECT SENSOR AND BIOZ TECT CABLE IMPEDANCE PLETHYSMOGRAPHDSB2000-05-05
1631691315374298K001081BIOZ.PC HEMODYNAMIC MONITOR MODEL BZ-500/BZ-501; BIOZ.PC USER SOFTWARE INSTALLATION KIT MODEL BZ-810DSB2000-06-30

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
IYN392025-11-03
DSB112011-06-03
IYO42011-12-29
ITX22010-08-12
OMF12010-08-23

PMN#

GUDID#

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