FDA.reportPublic FDA data

SAMSUNG MEDISON CO., LTD.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30097581863009758186SAMSUNG MEDISON CO., LTD.1N2026-01-01244, 1gongdan-ro Gumi-si Gyeongbuk KR 39376

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1589821269123589K263182EVO X30 Diagnostic Ultrasound System; EVO X20 Diagnostic Ultrasound System; EVO X10 Diagnostic Ultrasound System; EVO XP30 Diagnostic Ultrasound System; EVO XP20 Diagnostic Ultrasound System; EVO XP10 Diagnostic Ultrasound System; EVO XC30 Diagnostic Ultrasound System; EVO XC20 Diagnostic Ultrasound System; EVO XC10 Diagnostic Ultrasound SystemIYN2026-09-25
1589821233697458K261412V8/XV8/XH8/H8/cV8/V8 ONE/XV8 ONE/XH8 ONE/H8 ONE/cV8 ONE Diagnostic Ultrasound System; V7/XV7/XH7/H7/cV7/V7 ONE/XV7 ONE/H7 ONE/XH7 ONE/cV7 ONE Diagnostic Ultrasound System; V6/XV6/XH6/H6/cV6/V6 ONE/XV6 ONE/H6 ONE/XH6 ONE/cV6 ONE Diagnostic Ultrasound System; V5/XV5/XH5/H5/cV5 Diagnostic Ultrasound System; V4/XV4/XH4/H4/cV4 Diagnostic Ultrasound System;IYN2026-07-28
1589821099597214K254099EVO 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
1589821870412191K252018HERA 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
1589822058838103K250999
1589821617058686K243702V8 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
1589821927729080K242511V5 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
1589821379388075K242444HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound SystemIYN2024-11-27
1589822019287039K241971HERA Z20, R20, HERA Z30, R30 Diagnostic Ultrasound SystemIYN2024-10-11
1589821371206065K240631V8/XV8/XH8, V7/XV7/XH7, V6/XV6/XH6 Diagnostic Ultrasound SystemIYN2024-06-21
1589821491925418K240516RS85 Diagnostic Ultrasound SystemIYN2024-06-12
1589821151022392K233112HM70 EVO Diagnostic Ultrasound SystemIYN2023-12-21
1589821426997687K231772V8/H8 Diagnostic Ultrasound System, V7/H7 Diagnostic Ultrasound System, V6/H6 Diagnostic Ultrasound SystemIYN2023-10-03
1589821400358812K230084HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound SystemIYN2023-04-21
1589821829779397K223387V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound SystemIYN2023-02-13
1589821109229600K221599HS40 Diagnostic Ultrasound SystemIYN2022-08-22
1589821144264879K221117RS85 Diagnostic Ultrasound System, RS80 EVO Diagnostic Ultrasound SystemIYN2022-06-17
1589821775163437K220975V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound SystemIYN2022-06-29
1589821829735369K220269HM70 EVO Diagnostic Ultrasound SystemIYN2022-05-06
1589821664593115K220043HERA W10 Diagnostic Ultrasound System, HERA W9 Diagnostic Ultrasound SystemIYN2022-04-05
1589822050794373K211945V8 Diagnostic Ultrasound SystemIYN2021-09-08
1589821166333751K211824HERA W9, HERA W10 Diagnostic Ultrasound SystemIYN2021-09-09
1589822038132311K210959RS85 Diagnostic Ultrasound System, RS80 EVO Diagnostic Ultrasound SystemIYN2021-06-24
1589821446418381K210713HM70 EVO Diagnostic Ultrasound SystemIYN2021-07-09
1589821853946395K210426HS40 Diagnostic Ultrasound SystemIYN2021-05-13
1589821888470964K210068HS50 Diagnostic Ultrasound System, HS60 Diagnostic Ultrasound SystemIYN2021-04-09
1589821750996036K202556HS30 Diagnostic Ultrasound SystemIYN2020-10-30
1589821299013997K200699HS70A Diagnostic Ultrasound SystemIYN2020-05-07
1589821762245421K200339HS40 Diagnostic Ultrasound SystemIYN2020-04-07
1589821058865498K192903RS85 Diagnostic Ultrasound SystemIYN2020-01-06
1589821109512604K192505HS50/HS60 Diagnostics Ultrasound SystemIYN2019-12-12
1589821798113492K192319HERA W9 Diagnostic Ultrasound System, HERA W10 Diagnostic Ultrasound SystemIYN2019-12-10
1589821011980045K192030RS80 EVO Diagnostic Ultrasound SystemIYN2019-09-19
1589821885829224K191115RS85 Diagnostic Ultrasound SystemIYN2019-06-12
1589821264391793K191055HS40 Diagnostic Ultrasound SystemIYN2019-06-12
1589821206131491K190444HERA I10 Diagnostic Ultrasound SystemIYN2019-05-22
1589821290124925K182932RS85 Diagnostic Ultrasound SystemIYN2019-02-15
1589821196632914K182894HM70A Diagnostic Ultrasound SystemIYN2019-01-22
1589821634743947K182632HS30 Diagnostic Ultrasound SystemIYN2019-01-08
1589821374329923K182595HERA W10 Diagnostic Ultrasound SystemIYN2018-12-18
1589821898528785K181336HS50 / HS60 Diagnostic Ultrasound SystemIYN2018-12-04
1589821779925571K1808835D ViewerLLZ2018-05-15
1589821351270061K180409HS40 Diagnostic Ultrasound SystemIYN2018-05-11
1589821656728394K173713HS70A Diagnostic Ultrasound SystemIYN2018-03-08
1589821202883056K173513WS80A Diagnostic Ultrasound SystemIYN2018-02-20
1589821951153992K173204RS85 Diagnostic Ultrasound SystemIYN2018-02-05
1589822067727117K172129HS40 Diagnostic Ultrasound SystemIYN2017-08-08
1589821924771774K171070WS80A Diagnostic Ultrasound SystemIYN2017-08-09
1589821532859836K171048RS80A Diagnostic Ultrasound SystemIYN2017-08-24
1589821078317780K170493HS50 / HS60 Diagnostic Ultrasound SystemIYN2017-03-28
1589821556741344K163691HS70A Diagnostic Ultrasound SystemIYN2017-02-22
1589821157044564K162094RS80A Diagnostic Ultrasound SystemIYN2016-08-26
1589821594581635K1619555D ViewerLLZ2016-08-10
1589821916035242K153539RS80A Diagnostic Ultrasound SystemIYN2016-10-03
1589821381111482K153529WS80A Diagnostic Ultrasound SystemIYN2016-02-02
1589821490153517K153408HM70A Diagnostic Ultrasound SystemIYN2015-12-21
1589821726102702K152962HS70A Diagnostic Ultrasound SystemIYN2015-11-02
1589821623571948K1518083D/5D ViewerLLZ2015-07-29
1589821226510040K151663RS80A Diagnostic Ultrasound SystemIYN2015-08-12
1589821221982646K150478A35 Diagnostic Ultrasound SystemIYN2015-03-26
1589821454901998K143264H60 V2.00 Diagnostic Ultrasound SystemIYN2014-12-09
1589821789526312K143089WS80A Diagnostic Ultrasound SystemIYN2014-11-26
1589821129247848K142466UGEO PT60A Diagnostic Ultrasound SystemIYN2014-10-03
1589821156605133K141620RS80A DIAGNOSTIC ULTRASOUND SYSTEMIYN2014-07-02
1589821733410849K133505SONOACE R7 DIAGNOSTIC ULTRASOUND SYSTEMIYN2013-12-27
1589822054954055K133329UGEO WS80A DIAGNOSTIC ULTRASOUND SYSTEMIYN2013-11-27
1589821867720744K132861UGEO H60 DIAGNOSTIC ULTRASOUND SYSTEMIYN2013-10-04
1589821465426949K132228UGEO PT60A DIAGNOSTIC ULTRASOUND SYSTEMIYO2013-08-20
1589821984237057K130803UGEO H70C DIAGNOSTIC ULTRASOUND SYSTEMIYN2013-04-12
1589821760234871K122583UGEO G60 DIAGNOSTIC ULTRASOUND SYSTEMIYN2012-09-05
1589821596921475K113381MYSONO U6 DIAGNOSTIC ULTRASOUND SYSTEMIYN2011-12-29
1589821407644398K112646SONOACE R7 DIAGNOSTIC ULTRASOUND SYSTEMIYN2011-10-12
1589821553018378K112339ACCUVIX A30 DIAGNOSTIC ULTRASOUND SYSTEMIYN2011-08-29
1589821295813549K103722THE SONOACE R5 DIAGNOSTIC ULTRASOUND SYSTEMITX2011-01-05
1589821633419079K103397ACCUVIX XG DIAGNOSTIC ULTRASOUND SYSTEMIYN2011-02-25
1589821879926817K102065SONOACE R7 DIAGNOSTIC ULTRASOUND SYSTEMIYN2010-08-06
1589821203479378K101829THE SONOACE R3 DIAGNOSTIC ULTRASOUND SYSTEMITX2010-07-16
1589821594354063K101455EKO 7 DIAGNOSTIC ULTRASOUND SYSTEMIYN2010-07-19
1589821897494478K100186MYSONO U5 DIAGNOSTIC ULTRASOUND SYSTEMIYN2010-03-24
1589821661530625K093849ACCUVIX V10 DIAGNOSTIC ULTRASOUND SYSTEMIYN2010-01-19
1589821294620617K093714SONOACE X8 DIAGNOSTIC ULTRASOUND SYSTEMITX2009-12-10
1589821552403212K092159ACCUVIX V20 DIAGNOSTIC ULTRASOUND SYSTEMIYN2009-07-28
1589822011828330K081676SONOACE X6 DIAGNOSTIC ULTRASOUND SYSTEMIYN2008-07-02
1589821894793999K080800ACCUVIX V20 DIAGNOSTIC ULTRASOUND SYSTEMIYN2008-04-07
1589821413343160K070813ACCUVIX V10 DIAGNOSTIC ULTRASOUND SYSTEMIYN2007-04-10
1589821492832235K063580SONOACE X8 DIAGNOSTIC ULTRASOUND SYSTEMIYN2006-12-14
1589822056502714K053530SONOACE X4 DIAGNOSTIC ULTRASOUND SYSTEMIYN2006-01-03
1589822008980414K052911ACCUVIX XQ DIAGNOSTIC ULTRASOUND SYSTEMIYN2005-10-31
1589821620344903K043455SA8000 SE DIAGNOSTIC ULTRASOUND SYSTEMIYN2004-12-21
1589821450399881K031886SONOVIEW PRO BY MEDISON CO., LTD.LLZ2003-06-30
1589821107617306K013627SONOACE SA-8000 DIAGNOSTIC ULTRASOUND SYSTEMIYN2001-11-16

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
IYN832026-09-25
LLZ42018-05-15
ITX32011-01-05
IYO12013-08-20

PMN#

48 records. Showing 1-40. Next

GUDID#

200 records. Showing 1-40. Next