SonoSite IViz Ultrasound System
FUJIFILM SONOSITE,INC.
FUJIFILM SONOSITE,INC.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3032367 | 3002087856 | FUJIFILM SONOSITE,INC. | 1 | N | 2026-01-01 | 21919 30th Dr SE BOTHELL WA US 98021 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 163169 | 1615620040 | K994096 | SONOHEART HAND-CARRIED ECHOCARDIOGRAPHY SYSTEM | IYN | 1999-12-20 |
| 163169 | 1838858351 | K990806 | C1 ULTRASOUND SYSTEM | IYN | 1999-03-26 |
| 163169 | 1071058980 | K981505 | COZUMEL DIAGNOSTIC ULTRASOUND SYSTEM | IYO | 1998-05-08 |
| 163169 | 1728685296 | K974725 | BIOZ.COM SYSTEM | DSB | 1998-03-18 |
| 163169 | 1591346241 | K972320 | BIOZ SYSTEM & BIOZ PORTABLE | DSB | 1997-09-11 |
| 163169 | 1354690595 | K260595 | Sonosite iLOOK Ultrasound System | IYN | 2026-03-10 |
| 163169 | 1304088981 | K253448 | Sonosite MT Ultrasound System | IYN | 2025-11-03 |
| 163169 | 1727641030 | K251830 | Sonosite LX Ultrasound System | IYN | 2025-07-10 |
| 163169 | 1220781925 | K251106 | Sonosite LX and Sonosite PX Ultrasound Systems | IYN | 2025-08-29 |
| 163169 | 1531730196 | K233597 | Sonosite LX Ultrasound System | IYN | 2023-12-06 |
| 163169 | 1108700126 | K213763 | Sonosite PX Ultrasound System | IYN | 2021-12-27 |
| 163169 | 1968139254 | K200964 | Sonosite PX Ultrasound System | IYN | 2020-05-08 |
| 163169 | 1536826409 | K190476 | FUJIFILM Sonosite Vevo MD Imaging System | IYN | 2019-03-15 |
| 163169 | 1571034959 | K183235 | SonoSite SII Ultrasound System | IYN | 2019-02-07 |
| 163169 | 1553652158 | K180704 | SonoSite iViz Ultrasound System | IYN | 2018-04-13 |
| 163169 | 1437925549 | K171437 | SonoSite X-Porte Ultrasound System | IYN | 2017-06-12 |
| 163169 | 1575555244 | K162288 | SonoSite iViz Ultrasound System | IYN | 2016-09-08 |
| 163169 | 1385654955 | K162045 | SonoSite SII Ultrasound System, SonoSite Edge II Ultrasound System | IYN | 2016-08-18 |
| 163169 | 1831613796 | K161119 | SonoSite iViz Ultrasound System | IYN | 2016-05-13 |
| 163169 | 1304303830 | K160734 | SonoSite SII Ultrasound System | IYN | 2016-04-05 |
| 163169 | 1666851779 | K160674 | Fujifilm Sonosite Vevo MD Imaging System | IYN | 2016-04-19 |
| 163169 | 1979888110 | K160406 | FUJIFILM FC1 Ultrasound System | IYN | 2016-03-16 |
| 163169 | 1879435364 | K153626 | SonoSite Edge II Ultrasound System | IYN | 2016-01-20 |
| 163169 | 1403609329 | K152983 | FUJIFILM SonoSite iViz Ultrasound System | IYN | 2015-11-12 |
| 163169 | 1089522969 | K152209 | FUJIFILM SonoSite X-Porte Ultrasound System | IYN | 2015-08-19 |
| 163169 | 1124394314 | K142017 | X-PORTE ULTRASOUND SYSTEM | IYN | 2014-08-22 |
| 163169 | 1292764190 | K133454 | SONOSITE EDGE ULTRASOUND SYSTEM | IYN | 2013-12-16 |
| 163169 | 1436799859 | K133134 | X-PORTE ULTRASOUND SYSTEM | IYN | 2013-11-04 |
| 163169 | 1537629172 | K130173 | SONOSITE MAXX SERIES ULTRASOUND SYSTEM | IYN | 2013-03-25 |
| 163169 | 1299941633 | K113680 | SOMA ACCESS SYSTEMS EXACTTRACK PROCEDURE KIT | IYO | 2011-12-29 |
| 163169 | 2018621245 | K113156 | SONOSITE EDGE ULTRASOUND SYSTEM | IYO | 2011-11-15 |
| 163169 | 1750976372 | K110645 | BIO Z CARDIO PROFILE HEMODYNAMIC MONITOR | DSB | 2011-06-03 |
| 163169 | 1103963268 | K102390 | SONOSITE NANOMAXX SERIES ULTRASOUND SYSTEM | IYN | 2010-11-19 |
| 163169 | 2036245729 | K101757 | SONOSITE NANOMAXX SERIES ULTRASOUND SYSTEM, SONOSITE MAXX SERIES ULTRASOUND SYSTEM | ITX | 2010-08-12 |
| 163169 | 1563660110 | K093510 | LUMENVU CATHETER GUIDANCE SYSTEM | OMF | 2010-08-23 |
| 163169 | 1653814404 | K092058 | SONOSITE NANOMAXX SERIES ULTRASOUND SYSTEM | IYN | 2009-10-02 |
| 163169 | 1582621946 | K090602 | CARDIODYNAMICS BIOZ RX, MODEL 7101-SYS | DSB | 2009-05-28 |
| 163169 | 1711180377 | K082098 | SONOSITE MAXX SERIES ULTRASOUND SYSTEM | IYN | 2008-08-25 |
| 163169 | 1575106625 | K071134 | SONOSITE MAXX SERIES DIAGNOSTIC ULTRASOUND SYSTEM | IYO | 2007-05-08 |
| 163169 | 1469704418 | K070156 | BIOZ DX HEMODYNAMIC MONITOR WITH PHILIPS 12-LEAD ECG, MODEL 5100 | DSB | 2007-09-26 |
| 163169 | 1878856823 | K053069 | SONOSITE MICROMAXX DIAGNOSTIC ULTRASOUND SYSTEM (C3 SERIES) | IYN | 2005-11-16 |
| 163169 | 1655652509 | K052109 | SONOSITE HAND-CARRIED ULTRASOUND SYSTEM (C1 SERIES) | IYN | 2005-08-11 |
| 163169 | 1418926130 | K051228 | BIOZDX HEMODYNAMIC MONITOR AND 12-LEAD ECG | DSB | 2005-06-10 |
| 163169 | 1423894959 | K043559 | SONOSITE HIGH-RESOLUTION DIAGNOSTIC ULTRASOUND SYSTEM (C3 SERIES) | IYN | 2005-01-12 |
| 163169 | 1927570328 | K043452 | TITAN HIGH RESOLUTION ULTRASOUND SYSTEM AND SONOSITE ULTRASOUND SYSTEM | IYN | 2004-12-21 |
| 163169 | 1948776630 | K041294 | BIOZDX HEMODYNAMIC MONITOR | DSB | 2004-12-08 |
| 163169 | 1686124739 | K033367 | TITAN ULTRASOUND SYSTEM, SONOSITE ILOOK 25 ULTRASOUND SYSTEM, 180PLUS ULTRASOUND SYSTEM, MODEL L03073, L02245, L02464 | IYN | 2003-11-05 |
| 163169 | 1465348880 | K030949 | TITAN HIGH RESOLUTION ULTRASOUND SYSTEM | IYN | 2003-04-07 |
| 163169 | 2004458827 | K030064 | ILOOK 25 NEEDLE GUIDE ATTACHMENT AND BRACKET ASSEMBLY | ITX | 2003-01-22 |
| 163169 | 1452231107 | K023957 | SONOSITE HAND-CARRIED ULTRASOUND SYSTEM (C2 SERIES) | IYN | 2002-12-12 |
| 163169 | 1358247110 | K021628 | SONOSITE HAND-CARIED UNTRASOUND SYSTEM (POWERSERIES) | IYN | 2002-05-31 |
| 163169 | 1977724275 | K014116 | HAND-CARRIED ULTRASOUND SYSTEM | IYN | 2001-12-20 |
| 163169 | 1110571033 | K011797 | BIOZTECT SENSOR AND BIOZTECT CABLE | DSB | 2001-07-03 |
| 163169 | 1037724774 | K011439 | MODIFICATION TO BIOZ.COM HEMODYNAMIC MONITOR | DSB | 2001-11-02 |
| 163169 | 1857987317 | K010374 | SONOSITE HAND-CARRIED ULTRASOUND SYSTEM | IYN | 2001-02-21 |
| 163169 | 1447897123 | K003399 | SONOSITE HAND-CARRIED ULTRASOUND SYSTEM | IYN | 2000-11-16 |
| 163169 | 2067956865 | K001100 | BIOZ.COM HEMODYNAMIC MONITOR WITH BIOZ TECT SENSOR AND BIOZ TECT CABLE IMPEDANCE PLETHYSMOGRAPH | DSB | 2000-05-05 |
| 163169 | 1315374298 | K001081 | BIOZ.PC HEMODYNAMIC MONITOR MODEL BZ-500/BZ-501; BIOZ.PC USER SOFTWARE INSTALLATION KIT MODEL BZ-810 | DSB | 2000-06-30 |
Product Codes Associated With Registrations#
PMN#
SonoSite Edge II Ultrasound System
FUJIFILM SONOSITE,INC.
FUJIFILM SonoSite IViz Ultrasound System
FUJIFILM SONOSITE,INC.
FUJIFILM SonoSite X-Porte Ultrasound System
FUJIFILM SONOSITE,INC.
SONOSITE EDGE ULTRASOUND SYSTEM
FUJIFILM SONOSITE,INC.
X-PORTE ULTRASOUND SYSTEM
FUJIFILM SONOSITE,INC.
SONOSITE MAXX SERIES ULTRASOUND SYSTEM
FUJIFILM SONOSITE,INC.