GE VINGMED ULTRASOUND A/S

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
9610482	3002808457	GE VINGMED ULTRASOUND A/S	1	N	2026-01-01	STRANDPROMENADEN 45 HORTEN Vestfold NO 3191

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
26618	1913849570	K261835	LOGIQ Focus	IYN	2026-07-30
26618	1217580435	K261668	Venue Go	IYN	2026-08-07
26618	1273808789	K261623	EchoPAC Software Only / EchoPAC Plug-in (v211)	QIH	2026-09-16
26618	1928398916	K261313	Vivid Explorer/Vivid Advanced/Vivid Focus	IYN	2026-09-02
26618	1228006311	K260673	LOGIQ Vita; LOGIQ Vita Pro; LOGIQ Vita Express; LOGIQ Vita Plus; LOGIQ Vita Power; LOGIQ S20; LOGIQ S20 Pro; LOGIQ S20 Express; LOGIQ S20 Plus; LOGIQ S20 Power	IYN	2026-03-24
26618	2053786010	K260398	LOGIQ e	IYN	2026-05-26
26618	1695495357	K253370	LOGIQ Totus	IYN	2026-01-08
26618	1684322365	K253366	LOGIQ Fortis	IYN	2026-01-07
26618	2053695773	K251985	LOGIQ E10	IYN	2025-10-29
26618	1078030117	K251963	LOGIQ E10s	IYN	2025-10-29
26618	1146383654	K251342	EchoPAC Software Only / EchoPAC Plug-in	QIH	2025-07-16
26618	1846202890	K251322	Venue; Venue Go; Venue Fit; Venue Sprint	IYN	2025-07-25
26618	1040314840	K251169	Vivid Pioneer	IYN	2025-07-10
26618	1495978933	K250087	Vscan Air	IYN	2025-05-01
26618	1273874788	K243628	Vivid T9/Vivid T8	IYN	2025-02-11
26618	1905736941	K243620	Vivid iq	IYN	2025-02-11
26618	1955831828	K242005	Versana Premier; Versana Premier Lotus; LOGIQ F	IYN	2024-10-02
26618	1829127751	K240111	Venue	IYN	2024-06-10
26618	1060568579	K240053	Venue Go	IYN	2024-06-10
26618	1574908925	K234106	Venue Fit	IYN	2024-06-10
26618	1233237274	K232381	LOGIQ Totus	IYN	2023-12-07
26618	1507556663	K232186	LOGIQ e	IYN	2023-11-03
26618	1680768656	K231989	LOGIQ E10s, LOGIQ Fortis	IYN	2023-11-07
26618	1803846471	K231966	LOGIQ E10	IYN	2023-11-07
26618	1056074413	K231301	Vscan Air	IYN	2023-08-15
26618	1550945944	K223832	Vivid S60N, Vivid S70N	IYN	2023-02-16
26618	1496863674	K221148	Vivid iq	IYN	2022-07-18
26618	1355744278	K221147	Vivid T8, Vivid T9	IYN	2022-07-18
26618	1599444253	K220940	EchoPAC Software Only, EchoPAC Plug-in	QIH	2022-07-22
26618	1849210467	K220882	Vivid E80, Vivid E90, Vivid E95	IYN	2022-07-22
26618	1470155993	K220851	Venue	IYN	2022-06-27
26618	1207379269	K220848	Venue Fit	IYN	2022-06-27
26618	1255747394	K220800	Venue Go	IYN	2022-06-21
26618	1583853416	K220619	Vivid S60N, Vivid S70N	IYN	2022-07-15
26618	1665287961	K214039	LOGIQ P10, LOGIQ P9, LOGIQ P8	IYN	2022-03-22
26618	1828249342	K211524	LOGIQ E10s, LOGIQ Fortis	IYN	2021-08-27
26618	1373506904	K211488	LOGIQ E10	IYN	2021-09-10
26618	1215438851	K211216	Vivid S60N / Vivid S70N	IYN	2021-06-09
26618	1045794044	K203137	Venue Fit	IYN	2020-12-29
26618	1860949993	K203114	LOGIQ P10, LOGIQ P9, LOGIQ P8	IYN	2021-01-08
26618	2049977122	K202658	Vivid E80/ Vivid E90/ Vivid E95	IYN	2021-03-05
26618	1320605005	K202233	Venue Go	IYN	2020-11-18
26618	1480472745	K202132	Venue	IYN	2020-11-13
26618	1270929667	K202035	Vscan Air	ITX	2020-11-20
26618	1474598432	K200852	EchoPAC Software Only, EchoPAC Plug-In	LLZ	2020-09-18
26618	1085334430	K200851	Vivid T8, Vivid T9	IYN	2020-09-09
26618	1657862593	K200743	Vivid E80/ Vivid E90/ Vivid E95	IYN	2020-07-23
26618	1803578892	K200708	Vivid iq	IYN	2020-09-09
26618	1041951822	K200497	Vivid S60N, Vivid S70N	IYN	2020-07-16
26618	1736355325	K200158	LOGIQ E10	IYN	2020-04-17
26618	1862225688	K200119	LOGIQ E10s	IYN	2020-04-01
26618	1545666808	K192159	Voluson E6, Voluson E8, Voluson E10	IYN	2019-08-29
26618	1457689308	K183362	Venue GO	IYN	2019-01-28
26618	1901623583	K182450	Vivid S60N, Vivid S70N	IYN	2018-10-19
26618	1975945052	K181985	Voluson E6, Voluson E8, Voluson E10	IYN	2018-11-15
26618	1745719114	K181934	Vivid T8, Vivid T9	IYN	2018-11-06
26618	2007831697	K181783	LOGIQ P9; LOGIQ P7	IYN	2018-09-20
26618	1565149051	K181727	Vivid iq	IYN	2018-12-06
26618	1649812527	K181685	Vivid E80, Vivid E90, Vivid E95	IYN	2018-10-25
26618	1451298112	K180995	Vscan Extend	IYN	2018-06-25
26618	1426315530	K180599	Venue	IYN	2018-05-02
26618	1260621496	K173555	LOGIQ E10	IYN	2017-12-20
26618	1153581817	K173341	Vivid E80, Vivid E90, Vivid E95	IYN	2017-11-02
26618	1018031851	K172342	Voluson E6, Voluson E8, Voluson E10	IYN	2017-09-29
26618	1468837388	K170878	Vivid S60N, Vivid S70N	IYN	2017-06-14
26618	1702172961	K170847	EchoPAC Software Only, EchoPAC Plug-in	LLZ	2017-06-14
26618	1449109060	K170823	Vivid E80, Vivid E90, Vivid E95	IYN	2017-06-12
26618	1574494153	K170445	LOGIQ S8	IYN	2017-04-11
26618	1454914260	K163596	LOGIQ P9 and LOGIQ P7	IYN	2017-02-10
26618	1325329541	K163077	LOGIQ E9, LOGIQ E9 XDClear 2.0	IYN	2016-11-17
26618	1049862273	K162269	Voluson E6, Voluson E8, Voluson E10	IYN	2016-10-03
26618	1081354306	K161706	Vivid iq	IYN	2016-08-05
26618	1967158516	K161588	Vscan Extend	IYN	2016-08-31
26618	1599852132	K160182	LOGIQ S7 Expert	IYN	2016-02-26
26618	1696609696	K160078	Vivid T8	IYN	2016-03-10
26618	1246173604	K152309	LOGIQ E9, LOGIQ E9 XDClear 2.0	IYN	2015-09-14
26618	1327741506	K152195	LOGIQ S8	IYN	2015-09-29
26618	1664569213	K151028	LOGIQ e	IYN	2015-06-18
26618	1491990043	K150087	Vivid E80 Diagnostic Ultrasound Imaging System, Vivid E90 Diagnostic Ultrasound Imaging System, Vivid E95 Diagnostic Ultrasound Imaging System	IYN	2015-03-04
26618	1196560382	K150085	GE EchoPAC	LLZ	2015-03-02
26618	1017684941	K142472	Voluson E6 / Voluson E8 / Voluson E10 Diagnostic Ultrasound Systems	IYN	2015-02-10
26618	2033144035	K142323	Vivid S60 Diagnostic Ultrasound System, Vivid S70 Diagnostic Ultrasound System	IYN	2014-10-10
26618	1253903947	K142160	LOGIQ E9 DIAGNOSTIC ULTRASOUND SYSTEM	IYN	2014-10-10
26618	1071929123	K141639	VOLUSON S6, VOLUSON S8	IYN	2014-07-18
26618	1358923234	K141261	LOGIQ S7 EXPERT, LOGIQ S7 PRO	IYN	2014-06-05
26618	1882897907	K141093	6VT-D ULTRASOUND TRANSDUCER	ITX	2014-05-15
26618	1964616286	K141067	VIVID T8/VIVID T8 PRO	IYN	2014-05-23
26618	1809933600	K140693	VSCAN WITH DUAL PROBE	IYN	2014-05-16
26618	1143881808	K132913	VOLUSON E6 / E8 / E8EXPERT / E8EXPERT LIMITED EDITION / E10	IYN	2013-11-08
26618	2009633074	K131685	GE ECHOPAC	LLZ	2013-09-24
26618	1412435246	K131527	LOGIQ S8	IYN	2013-08-26
26618	1605730960	K131514	GE VIVID E9 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM	IYN	2013-07-12
26618	1428706471	K131267	VOLUSON E6/E8/E8EXPERT/E8EXPERT LIMITED EDITION/E10	IYN	2013-06-19
26618	1614480084	K123894	GE ECHOPAC	LLZ	2013-01-29
26618	1144953580	K123564	LOGIQ E9 DIAGNOSTIC ULTRASOUND SYSTEM	IYN	2012-12-18
26618	1252456979	K122327	VOLUSON E6/E8/E8EXPERT/E10	IYN	2012-09-21
26618	1102924704	K122114	LOGIQ S7 EXPERT, LOGIQ S7 PRO	IYN	2012-10-03
26618	1568772841	K121063	VIVID S5 DIAGNOSTIC ULTRASOUND SYSTEM, VIVID S6 DIAGNOSTIC ULTRASOUND SYSTEM	IYN	2012-08-21
26618	1135286259	K121062	VIVID I DIAGNOSTIC ULTRASOUND SYSTEM, VIVID Q DIAGNOSTIC ULTRASOUND SYSTEM	ITX	2012-08-17
26618	1157404157	K120741	VOLUSON S6, VOLUSON S8	IYN	2012-04-27
26618	1364599109	K120221	GE ECHOPAC	LLZ	2012-03-30
26618	1720098721	K120201	GE VIVID E9 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM	IYO	2012-04-19
26618	1365724895	K113690	GE LOGIQ I, LOGIQ E AND VIVID E	IYN	2011-12-29
26618	1204743655	K112213	VOLUSON E6, E8, E8 EXPERT, E10 DIAGNOSTIC ULTRASOUND SYSTEM	IYN	2011-09-01
26618	1693793390	K111582	LOGIQ S8	IYN	2011-07-26
26618	2022372250	K110943	LOGIQ E9	IYN	2011-07-22
26618	1497175299	K102393	VIVID S5 DIAGNOSTIC ULTRASOUND SYSTEM; VIVID S6 DIAGNOSTICULTRASOUND SYSTEM	IYO	2010-11-05
26618	1991922374	K102388	VIVID I DIAGNOSTIC ULTRASOUND SYSTEM	IYN	2010-11-04
26618	1590880624	K101878	GE LOGIQ P5 MODEL H44662LD	IYN	2010-08-31
26618	1353579866	K101874	GE LOGIQ P6/P6 PRO	IYN	2010-10-05
26618	1733288605	K101324	GE ECHOPAC MODEL BT10	LLZ	2010-10-05
26618	1052421172	K101236	VOLUSON E6/E8/E8 EXPERT DIAGNOSTIC ULTRASOUND SYSTEM MODEL: H48681BD/ H48681BX/ H48681BM	IYN	2011-02-08
26618	1837373273	K101149	GE VIVID E9 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM	IYO	2010-10-13
26618	1724923814	K092756	GE VSCAN COMPACT DIAGNOSTIC ULTRASOUND SYSTEM	ITX	2009-09-28
26618	1692661084	K092271	GE LOGIQ E9 BT2010 DIAGNOSTIC ULTRASOUND SYSTEM, MODEL 5205000-3, 5205000-4	IYN	2009-11-17
26618	1429802983	K092140	GE VIVID I DIAGNOSTIC ULTRASOUND, GE VIVID Q DIAGNOSTIC ULTRASOUND	IYO	2009-08-21
26618	1551876085	K092079	MODIFICATION TO GE VIVID S5 AND S6 DIAGNOSTIC ULTRASOUND	IYN	2009-08-06
26618	1392447587	K091374	GE LOGIQ I/E & VIVID E COMPACT ULTRASOUND	IYO	2009-05-26
26618	2034780922	K081921	GE VIVID E9 ULTRASOUND	IYN	2008-08-06

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
IYN	109	2026-09-02
LLZ	8	2020-09-18
IYO	6	2012-04-19
ITX	4	2020-11-20
QIH	3	2026-09-16

GUDID#

Vivid - Vivid Focus Console
GE Vingmed Ultrasound A/S
2026-09-21
Vivid - Vivid Explorer Console
GE Vingmed Ultrasound A/S
2026-09-21
Vivid - Vivid Advanced Console
GE Vingmed Ultrasound A/S
2026-09-21
Vscan - Vscan Air CL
GE Vingmed Ultrasound A/S
2025-07-04
EchoPAC - MD EchoPAC Software Only v206
GE Vingmed Ultrasound A/S
2022-08-23
EchoPAC - MD EchoPAC Plug-in v206
GE Vingmed Ultrasound A/S
2022-08-23
NA - 9VT-D
GE Vingmed Ultrasound A/S
2022-07-29
Vivid - Vivid E v204 4D ICE UPG
GE Vingmed Ultrasound A/S
2021-06-24
Vscan Air - Vscan Air R3.2 for Android
GE Vingmed Ultrasound A/S
2026-05-11
Vscan Air - Vscan Air R3.2 for iOS
GE Vingmed Ultrasound A/S
2026-05-11
Vivid - E80 v204 with OLED
GE Vingmed Ultrasound A/S
2020-08-12
Vivid - E80 v204 with LCD
GE Vingmed Ultrasound A/S
2020-08-12
Vivid - E90 v204 with OLED
GE Vingmed Ultrasound A/S
2020-08-12
Vivid - E90 v204 with LCD
GE Vingmed Ultrasound A/S
2020-08-12
Vscan - Vscan Air R3.1 for Android
GE Vingmed Ultrasound A/S
2025-11-17
Vscan - Vscan Air R3.1 for iOS
GE Vingmed Ultrasound A/S
2025-11-17
EchoPAC - MD EchoPAC Software Only v210
GE Vingmed Ultrasound A/S
2025-08-08
EchoPAC - MD EchoPAC Plug-In v210
GE Vingmed Ultrasound A/S
2025-08-08
Vivid - Vivid Pioneer v210
GE Vingmed Ultrasound A/S
2025-08-07
Vscan - Vscan Air R3 for Android
GE Vingmed Ultrasound A/S
2025-05-22
Vscan - Vscan Air R3 for iOS
GE Vingmed Ultrasound A/S
2025-05-22
Vscan - Vscan Air R2 for iOS
GE Vingmed Ultrasound A/S
2023-09-26
Vscan - Vscan Air R2 for Android
GE Vingmed Ultrasound A/S
2023-09-26
Vscan - Vscan Air R2 Upgrade kit
GE Vingmed Ultrasound A/S
2023-09-26
Vscan - Vscan Air SL
GE Vingmed Ultrasound A/S
2023-09-26
Vivid - Vivid E95 v206
GE Vingmed Ultrasound A/S
2022-09-20
Vivid - Vivid S70N v206 China
GE Vingmed Ultrasound A/S
2022-08-12
Vivid - Vivid S60N v206 China
GE Vingmed Ultrasound A/S
2022-08-12
Vivid - Vivid S70N v206 NOR
GE Vingmed Ultrasound A/S
2022-08-12
Vivid - Vivid S60N v206 NOR
GE Vingmed Ultrasound A/S
2022-08-12
Vivid - Vivid E80 v206
GE Vingmed Ultrasound A/S
2022-08-12
Vivid - Vivid E90 v206
GE Vingmed Ultrasound A/S
2022-08-12
Vivid - Vivid S70N S60N v203 v204 v205 to v206 Upg kit
GE Vingmed Ultrasound A/S
2022-08-12
Vivid - Vivid E95, E90, E80 v203 v204 to v206 UPG
GE Vingmed Ultrasound A/S
2022-08-12
Vivid - Vivid E95 v204 with OLED
GE Vingmed Ultrasound A/S
2020-08-12
Vivid - Vivid S70N v205 China
GE Vingmed Ultrasound A/S
2021-07-08
Vivid - Vivid S70N S60N v204 to v205 Upg kit
GE Vingmed Ultrasound A/S
2021-07-08
Vivid - Vivid S60N v205CH
GE Vingmed Ultrasound A/S
2021-07-01
Vivid - Vivid S70N v205 NOR
GE Vingmed Ultrasound A/S
2021-07-01
Vivid - Vivid S60N v205 NOR
GE Vingmed Ultrasound A/S
2021-07-01

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