FDA.reportPublic FDA data

Ninad Gujar

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
80411603010289997Ninad Gujar1N2026-01-0114 Electronics Ave Danvers MA US 01923
30119556793011955679Ninad Gujar1N2026-01-0114 Electronics Ave Danvers MA US 01923

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
114961099597214K254099EVO Q30 Diagnostic Ultrasound System; EVO Q20 Diagnostic Ultrasound System; EVO Q10 Diagnostic Ultrasound System; EVO XQ30 Diagnostic Ultrasound System; EVO XQ20 Diagnostic Ultrasound System; EVO XQ10 Diagnostic Ultrasound System; EVO QH30 Diagnostic Ultrasound System; EVO QH20 Diagnostic Ultrasound System; EVO QH10 Diagnostic Ultrasound SystemIYN2026-03-27
114961870412191K252018HERA Z20 Diagnostic Ultrasound System; HERA Z20e Diagnostic Ultrasound System; HERA Z20s Diagnostic Ultrasound System; R20 Diagnostic Ultrasound System; HERA Z30 Diagnostic Ultrasound System; R30 Diagnostic Ultrasound SystemIYN2026-01-05
114962058838103K250999V8 Diagnostic Ultrasound System; cV8 Diagnostic Ultrasound System; V7 Diagnostic Ultrasound System; cV7 Diagnostic Ultrasound System; V6 Diagnostic Ultrasound System; cV6 Diagnostic Ultrasound System; V5 Diagnostic Ultrasound System; cV5 Diagnostic Ultrasound System; V4 Diagnostic Ultrasound System; cV4 Diagnostic Ultrasound SystemIYN2025-07-18
114961617058686K243702V8 Diagnostic Ultrasound System; cV8 Diagnostic Ultrasound System; V7 Diagnostic Ultrasound System; cV7 Diagnostic Ultrasound System; V6 Diagnostic Ultrasound System; cV6 Diagnostic Ultrasound SystemIYN2025-02-12
114961927729080K242511V5 Diagnostic Ultrasound System, H5 Diagnostic Ultrasound System, XV5 Diagnostic Ultrasound System, XH5 Diagnostic Ultrasound System, V4 Diagnostic Ultrasound System, H4 Diagnostic Ultrasound System, XV4 Diagnostic Ultrasound System, XH4 Diagnostic Ultrasound SystemIYN2024-12-10
114961379388075K242444HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound SystemIYN2024-11-27
114962019287039K241971HERA Z20, R20, HERA Z30, R30 Diagnostic Ultrasound SystemIYN2024-10-11
114961199444653K241302SonoSyncLLZ2024-08-23
114961371206065K240631V8/XV8/XH8, V7/XV7/XH7, V6/XV6/XH6 Diagnostic Ultrasound SystemIYN2024-06-21
114961491925418K240516RS85 Diagnostic Ultrasound SystemIYN2024-06-12
114961151022392K233112HM70 EVO Diagnostic Ultrasound SystemIYN2023-12-21
114961426997687K231772V8/H8 Diagnostic Ultrasound System, V7/H7 Diagnostic Ultrasound System, V6/H6 Diagnostic Ultrasound SystemIYN2023-10-03
114961400358812K230084HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound SystemIYN2023-04-21
114961829779397K223387V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound SystemIYN2023-02-13
114961109229600K221599HS40 Diagnostic Ultrasound SystemIYN2022-08-22
114961144264879K221117RS85 Diagnostic Ultrasound System, RS80 EVO Diagnostic Ultrasound SystemIYN2022-06-17
114961775163437K220975V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound SystemIYN2022-06-29
114961829735369K220269HM70 EVO Diagnostic Ultrasound SystemIYN2022-05-06
114961664593115K220043HERA W10 Diagnostic Ultrasound System, HERA W9 Diagnostic Ultrasound SystemIYN2022-04-05
114962050794373K211945V8 Diagnostic Ultrasound SystemIYN2021-09-08
114961166333751K211824HERA W9, HERA W10 Diagnostic Ultrasound SystemIYN2021-09-09
114962038132311K210959RS85 Diagnostic Ultrasound System, RS80 EVO Diagnostic Ultrasound SystemIYN2021-06-24
114961446418381K210713HM70 EVO Diagnostic Ultrasound SystemIYN2021-07-09
114961853946395K210426HS40 Diagnostic Ultrasound SystemIYN2021-05-13
114961888470964K210068HS50 Diagnostic Ultrasound System, HS60 Diagnostic Ultrasound SystemIYN2021-04-09
114961750996036K202556HS30 Diagnostic Ultrasound SystemIYN2020-10-30
114961299013997K200699HS70A Diagnostic Ultrasound SystemIYN2020-05-07
114961762245421K200339HS40 Diagnostic Ultrasound SystemIYN2020-04-07
114961058865498K192903RS85 Diagnostic Ultrasound SystemIYN2020-01-06
114961109512604K192505HS50/HS60 Diagnostics Ultrasound SystemIYN2019-12-12
114961798113492K192319HERA W9 Diagnostic Ultrasound System, HERA W10 Diagnostic Ultrasound SystemIYN2019-12-10
114961011980045K192030RS80 EVO Diagnostic Ultrasound SystemIYN2019-09-19
114961885829224K191115RS85 Diagnostic Ultrasound SystemIYN2019-06-12
114961264391793K191055HS40 Diagnostic Ultrasound SystemIYN2019-06-12
114961206131491K190444HERA I10 Diagnostic Ultrasound SystemIYN2019-05-22
114961290124925K182932RS85 Diagnostic Ultrasound SystemIYN2019-02-15
114961196632914K182894HM70A Diagnostic Ultrasound SystemIYN2019-01-22
114961634743947K182632HS30 Diagnostic Ultrasound SystemIYN2019-01-08
114961374329923K182595HERA W10 Diagnostic Ultrasound SystemIYN2018-12-18
114961898528785K181336HS50 / HS60 Diagnostic Ultrasound SystemIYN2018-12-04
114961779925571K1808835D ViewerLLZ2018-05-15
114961351270061K180409HS40 Diagnostic Ultrasound SystemIYN2018-05-11
114961656728394K173713HS70A Diagnostic Ultrasound SystemIYN2018-03-08
114961202883056K173513WS80A Diagnostic Ultrasound SystemIYN2018-02-20
114961951153992K173204RS85 Diagnostic Ultrasound SystemIYN2018-02-05
114962067727117K172129HS40 Diagnostic Ultrasound SystemIYN2017-08-08
114961924771774K171070WS80A Diagnostic Ultrasound SystemIYN2017-08-09
114961532859836K171048RS80A Diagnostic Ultrasound SystemIYN2017-08-24
114961078317780K170493HS50 / HS60 Diagnostic Ultrasound SystemIYN2017-03-28
114961556741344K163691HS70A Diagnostic Ultrasound SystemIYN2017-02-22
114961157044564K162094RS80A Diagnostic Ultrasound SystemIYN2016-08-26
114961594581635K1619555D ViewerLLZ2016-08-10
114961916035242K153539RS80A Diagnostic Ultrasound SystemIYN2016-10-03
114961381111482K153529WS80A Diagnostic Ultrasound SystemIYN2016-02-02
114961490153517K153408HM70A Diagnostic Ultrasound SystemIYN2015-12-21
114961726102702K152962HS70A Diagnostic Ultrasound SystemIYN2015-11-02
114961623571948K1518083D/5D ViewerLLZ2015-07-29
114961226510040K151663RS80A Diagnostic Ultrasound SystemIYN2015-08-12
114961221982646K150478A35 Diagnostic Ultrasound SystemIYN2015-03-26
114961454901998K143264H60 V2.00 Diagnostic Ultrasound SystemIYN2014-12-09
114961789526312K143089WS80A Diagnostic Ultrasound SystemIYN2014-11-26
114961129247848K142466UGEO PT60A Diagnostic Ultrasound SystemIYN2014-10-03
114961156605133K141620RS80A DIAGNOSTIC ULTRASOUND SYSTEMIYN2014-07-02
114961733410849K133505SONOACE R7 DIAGNOSTIC ULTRASOUND SYSTEMIYN2013-12-27
114962054954055K133329UGEO WS80A DIAGNOSTIC ULTRASOUND SYSTEMIYN2013-11-27
114961867720744K132861UGEO H60 DIAGNOSTIC ULTRASOUND SYSTEMIYN2013-10-04
114961465426949K132228UGEO PT60A DIAGNOSTIC ULTRASOUND SYSTEMIYO2013-08-20
114961984237057K130803UGEO H70C DIAGNOSTIC ULTRASOUND SYSTEMIYN2013-04-12
114961760234871K122583UGEO G60 DIAGNOSTIC ULTRASOUND SYSTEMIYN2012-09-05
114961596921475K113381MYSONO U6 DIAGNOSTIC ULTRASOUND SYSTEMIYN2011-12-29
114961407644398K112646SONOACE R7 DIAGNOSTIC ULTRASOUND SYSTEMIYN2011-10-12
114961553018378K112339ACCUVIX A30 DIAGNOSTIC ULTRASOUND SYSTEMIYN2011-08-29
114961295813549K103722THE SONOACE R5 DIAGNOSTIC ULTRASOUND SYSTEMITX2011-01-05
114961633419079K103397ACCUVIX XG DIAGNOSTIC ULTRASOUND SYSTEMIYN2011-02-25
114961879926817K102065SONOACE R7 DIAGNOSTIC ULTRASOUND SYSTEMIYN2010-08-06
114961203479378K101829THE SONOACE R3 DIAGNOSTIC ULTRASOUND SYSTEMITX2010-07-16
114961594354063K101455EKO 7 DIAGNOSTIC ULTRASOUND SYSTEMIYN2010-07-19
114961897494478K100186MYSONO U5 DIAGNOSTIC ULTRASOUND SYSTEMIYN2010-03-24
114961661530625K093849ACCUVIX V10 DIAGNOSTIC ULTRASOUND SYSTEMIYN2010-01-19
114961294620617K093714SONOACE X8 DIAGNOSTIC ULTRASOUND SYSTEMITX2009-12-10
114961552403212K092159ACCUVIX V20 DIAGNOSTIC ULTRASOUND SYSTEMIYN2009-07-28
114962011828330K081676SONOACE X6 DIAGNOSTIC ULTRASOUND SYSTEMIYN2008-07-02
114961894793999K080800ACCUVIX V20 DIAGNOSTIC ULTRASOUND SYSTEMIYN2008-04-07
114961413343160K070813ACCUVIX V10 DIAGNOSTIC ULTRASOUND SYSTEMIYN2007-04-10
114961492832235K063580SONOACE X8 DIAGNOSTIC ULTRASOUND SYSTEMIYN2006-12-14
114962056502714K053530SONOACE X4 DIAGNOSTIC ULTRASOUND SYSTEMIYN2006-01-03
114962008980414K052911ACCUVIX XQ DIAGNOSTIC ULTRASOUND SYSTEMIYN2005-10-31
114961620344903K043455SA8000 SE DIAGNOSTIC ULTRASOUND SYSTEMIYN2004-12-21
114961450399881K031886SONOVIEW PRO BY MEDISON CO., LTD.LLZ2003-06-30
114961107617306K013627SONOACE SA-8000 DIAGNOSTIC ULTRASOUND SYSTEMIYN2001-11-16
114961186105062
114961197076917
3334381820895900

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
IYN812026-03-27
LLZ52024-08-23
ITX32011-01-05
IYO12013-08-20