GE PARALLEL DESIGN, INC.

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
2032350	3003309342	GE PARALLEL DESIGN, INC.	1	N	2026-01-01	4313 E COTTON CENTER BLVD STE 100 PHOENIX AZ US 85040

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
26598	1844139467	P110006	SOMO.V ABUS (AUTOMATED BREAST ULTRASOUND SYSTEM)	PAA	2012-09-18
26598	1673444285	K961002	DIASONICS ITNRAOPERATIVE PROBES	ITX	1997-01-22
26598	1913849570	K261835	LOGIQ Focus	IYN	2026-07-30
26598	1217580435	K261668	Venue Go	IYN	2026-08-07
26598	1928398916	K261313	Vivid Explorer/Vivid Advanced/Vivid Focus	IYN	2026-09-02
26598	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
26598	2053786010	K260398	LOGIQ e	IYN	2026-05-26
26598	1695495357	K253370	LOGIQ Totus	IYN	2026-01-08
26598	1684322365	K253366	LOGIQ Fortis	IYN	2026-01-07
26598	1111491994	K252328	Voluson Expert 18; Voluson Expert 20; Voluson Expert 22	IYN	2025-11-24
26598	2053695773	K251985	LOGIQ E10	IYN	2025-10-29
26598	1078030117	K251963	LOGIQ E10s	IYN	2025-10-29
26598	1846202890	K251322	Venue; Venue Go; Venue Fit; Venue Sprint	IYN	2025-07-25
26598	1040314840	K251169	Vivid Pioneer	IYN	2025-07-10
26598	1833596315	K250543	Voluson™ Performance 16; Voluson™ Performance 18	IYN	2025-05-29
26598	1273874788	K243628	Vivid T9/Vivid T8	IYN	2025-02-11
26598	1905736941	K243620	Vivid iq	IYN	2025-02-11
26598	1519616603	K242168	Voluson Expert 18; Voluson Expert 20; Voluson Expert 22	IYN	2024-12-20
26598	1955831828	K242005	Versana Premier; Versana Premier Lotus; LOGIQ F	IYN	2024-10-02
26598	1829127751	K240111	Venue	IYN	2024-06-10
26598	1060568579	K240053	Venue Go	IYN	2024-06-10
26598	1574908925	K234106	Venue Fit	IYN	2024-06-10
26598	1233237274	K232381	LOGIQ Totus	IYN	2023-12-07
26598	1507556663	K232186	LOGIQ e	IYN	2023-11-03
26598	1680768656	K231989	LOGIQ E10s, LOGIQ Fortis	IYN	2023-11-07
26598	1803846471	K231966	LOGIQ E10	IYN	2023-11-07
26598	1113056635	K231965	Voluson Expert 22, Voluson Expert 20, Voluson Expert 18	IYN	2023-10-30
26598	1146882666	K230346	Voluson SWIFT; Voluson SWIFT+	IYN	2023-06-20
26598	1550945944	K223832	Vivid S60N, Vivid S70N	IYN	2023-02-16
26598	1484427763	K223407	Versana Essential	IYN	2023-02-15
26598	1496863674	K221148	Vivid iq	IYN	2022-07-18
26598	1355744278	K221147	Vivid T8, Vivid T9	IYN	2022-07-18
26598	1849210467	K220882	Vivid E80, Vivid E90, Vivid E95	IYN	2022-07-22
26598	1470155993	K220851	Venue	IYN	2022-06-27
26598	1207379269	K220848	Venue Fit	IYN	2022-06-27
26598	1255747394	K220800	Venue Go	IYN	2022-06-21
26598	1583853416	K220619	Vivid S60N, Vivid S70N	IYN	2022-07-15
26598	1271216718	K220446	Versana Balance	IYN	2022-05-11
26598	1542794144	K220358	Voluson Expert 22, Voluson Expert 20, Voluson Expert 18	IYN	2022-06-06
26598	1665287961	K214039	LOGIQ P10, LOGIQ P9, LOGIQ P8	IYN	2022-03-22
26598	1395009610	K213689	Voluson P6, Voluson P8	IYN	2022-02-17
26598	1871704527	K213642	Voluson S6, Voluson S8, Voluson S8t, Voluson S10, Voluson S10 Expert	IYN	2022-01-13
26598	1828249342	K211524	LOGIQ E10s, LOGIQ Fortis	IYN	2021-08-27
26598	1373506904	K211488	LOGIQ E10	IYN	2021-09-10
26598	1215438851	K211216	Vivid S60N / Vivid S70N	IYN	2021-06-09
26598	1054366508	K210438	Versana Premier	IYN	2021-09-10
26598	1045794044	K203137	Venue Fit	IYN	2020-12-29
26598	1860949993	K203114	LOGIQ P10, LOGIQ P9, LOGIQ P8	IYN	2021-01-08
26598	2049977122	K202658	Vivid E80/ Vivid E90/ Vivid E95	IYN	2021-03-05
26598	1320605005	K202233	Venue Go	IYN	2020-11-18
26598	1480472745	K202132	Venue	IYN	2020-11-13
26598	1565719312	K201828	Voluson SWIFT, Voluson SWIFT+	IYN	2020-10-11
26598	1552540714	K200998	Versana Active	IYN	2020-06-11
26598	1085334430	K200851	Vivid T8, Vivid T9	IYN	2020-09-09
26598	1657862593	K200743	Vivid E80/ Vivid E90/ Vivid E95	IYN	2020-07-23
26598	1803578892	K200708	Vivid iq	IYN	2020-09-09
26598	1041951822	K200497	Vivid S60N, Vivid S70N	IYN	2020-07-16
26598	1736355325	K200158	LOGIQ E10	IYN	2020-04-17
26598	1615631748	K200138	Versana Premier	IYN	2020-07-01
26598	1862225688	K200119	LOGIQ E10s	IYN	2020-04-01
26598	1545666808	K192159	Voluson E6, Voluson E8, Voluson E10	IYN	2019-08-29
26598	1392054813	K191798	Versana Active	IYN	2019-08-09
26598	1045577832	K191792	Versana Balance	IYN	2019-08-09
26598	1457689308	K183362	Venue GO	IYN	2019-01-28
26598	1901623583	K182450	Vivid S60N, Vivid S70N	IYN	2018-10-19
26598	2014006386	K182277	Versana Premier	IYN	2018-11-21
26598	1975945052	K181985	Voluson E6, Voluson E8, Voluson E10	IYN	2018-11-15
26598	1745719114	K181934	Vivid T8, Vivid T9	IYN	2018-11-06
26598	2007831697	K181783	LOGIQ P9; LOGIQ P7	IYN	2018-09-20
26598	1565149051	K181727	Vivid iq	IYN	2018-12-06
26598	1649812527	K181685	Vivid E80, Vivid E90, Vivid E95	IYN	2018-10-25
26598	1341501258	K180641	Invenia ABUS Viewer	LLZ	2018-05-04
26598	1426315530	K180599	Venue	IYN	2018-05-02
26598	1355669882	K180535	Voluson P6 and Voluson P8	IYN	2018-03-29
26598	1206091853	K180374	Voluson S8/ Voluson S10/ Voluson S10 Expert	IYN	2018-03-13
26598	1260621496	K173555	LOGIQ E10	IYN	2017-12-20
26598	1153581817	K173341	Vivid E80, Vivid E90, Vivid E95	IYN	2017-11-02
26598	1018031851	K172342	Voluson E6, Voluson E8, Voluson E10	IYN	2017-09-29
26598	1468837388	K170878	Vivid S60N, Vivid S70N	IYN	2017-06-14
26598	1449109060	K170823	Vivid E80, Vivid E90, Vivid E95	IYN	2017-06-12
26598	1574494153	K170445	LOGIQ S8	IYN	2017-04-11
26598	1454914260	K163596	LOGIQ P9 and LOGIQ P7	IYN	2017-02-10
26598	1325329541	K163077	LOGIQ E9, LOGIQ E9 XDClear 2.0	IYN	2016-11-17
26598	1049862273	K162269	Voluson E6, Voluson E8, Voluson E10	IYN	2016-10-03
26598	1081354306	K161706	Vivid iq	IYN	2016-08-05
26598	1135478901	K161224	LOGIQ V5 Expert, LOGIQ V5, LOGIQ V3	IYN	2016-08-05
26598	1317418062	K161047	LOGIQ P9 and LOGIQ P7	IYN	2016-05-05
26598	1879277666	K160277	LOGIQ F8 Expert, LOGIQ F8, LOGIQ F6	IYN	2016-03-25
26598	1757886243	K160184	Voluson S6, Voluson S8, Voluson S10	IYN	2016-02-25
26598	1599852132	K160182	LOGIQ S7 Expert	IYN	2016-02-26
26598	1068620599	K160162	Voluson P6, Voluson P8	IYN	2016-04-26
26598	1696609696	K160078	Vivid T8	IYN	2016-03-10
26598	1350387500	K153037	LOGIQ V1/ LOGIQ V2	IYN	2016-01-04
26598	1319113126	K152567	Voluson E6, Voluson E8, Voluson E10 Diagnostic Ultrasound System	IYN	2015-11-06
26598	1246173604	K152309	LOGIQ E9, LOGIQ E9 XDClear 2.0	IYN	2015-09-14
26598	1327741506	K152195	LOGIQ S8	IYN	2015-09-29
26598	1664569213	K151028	LOGIQ e	IYN	2015-06-18
26598	1491990043	K150087	Vivid E80 Diagnostic Ultrasound Imaging System, Vivid E90 Diagnostic Ultrasound Imaging System, Vivid E95 Diagnostic Ultrasound Imaging System	IYN	2015-03-04
26598	1524790521	K143452	LOGIQ P9, LOGIQ P7	IYN	2015-01-29
26598	1017684941	K142472	Voluson E6 / Voluson E8 / Voluson E10 Diagnostic Ultrasound Systems	IYN	2015-02-10
26598	2033144035	K142323	Vivid S60 Diagnostic Ultrasound System, Vivid S70 Diagnostic Ultrasound System	IYN	2014-10-10
26598	1253903947	K142160	LOGIQ E9 DIAGNOSTIC ULTRASOUND SYSTEM	IYN	2014-10-10
26598	1415232989	K141768	LOGIQ V5/LOGIQ V3	IYN	2014-08-04
26598	1506431334	K141675	VOLUSON P6, VOLUSON P8	IYN	2014-07-25
26598	1071929123	K141639	VOLUSON S6, VOLUSON S8	IYN	2014-07-18
26598	1358923234	K141261	LOGIQ S7 EXPERT, LOGIQ S7 PRO	IYN	2014-06-05
26598	1964616286	K141067	VIVID T8/VIVID T8 PRO	IYN	2014-05-23
26598	2007487350	K133533	LOGIQ E	IYN	2014-02-12
26598	1695131102	K133034	LOGIQ F SERIES	IYN	2014-01-31
26598	1143881808	K132913	VOLUSON E6 / E8 / E8EXPERT / E8EXPERT LIMITED EDITION / E10	IYN	2013-11-08
26598	1313434568	K131937	VOLUSON I/E	IYN	2013-09-24
26598	1412435246	K131527	LOGIQ S8	IYN	2013-08-26
26598	1605730960	K131514	GE VIVID E9 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM	IYN	2013-07-12
26598	1428706471	K131267	VOLUSON E6/E8/E8EXPERT/E8EXPERT LIMITED EDITION/E10	IYN	2013-06-19
26598	1144953580	K123564	LOGIQ E9 DIAGNOSTIC ULTRASOUND SYSTEM	IYN	2012-12-18
26598	1690706897	K122387	VOLUSON P6, VOLUSON P8	IYN	2012-09-11
26598	1252456979	K122327	VOLUSON E6/E8/E8EXPERT/E10	IYN	2012-09-21
26598	1102924704	K122114	LOGIQ S7 EXPERT, LOGIQ S7 PRO	IYN	2012-10-03
26598	1568772841	K121063	VIVID S5 DIAGNOSTIC ULTRASOUND SYSTEM, VIVID S6 DIAGNOSTIC ULTRASOUND SYSTEM	IYN	2012-08-21

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
IYN	145	2026-09-02
IYO	7	2012-04-19
ITX	2	2012-08-17
LLZ	1	2018-05-04
PAA	1	2012-09-18

GUDID#

NA - ML4-20VN-D
GE PARALLEL DESIGN, INC.
2021-11-18
NA - 4C-D
GE PARALLEL DESIGN, INC.
2016-07-15
NA - 3S-RS
GE PARALLEL DESIGN, INC.
2016-07-15
NA - i12L-RS
GE PARALLEL DESIGN, INC.
2016-07-15
NA - 5S
GE PARALLEL DESIGN, INC.
2016-07-15
NA - 8L
GE PARALLEL DESIGN, INC.
2016-07-15
NA - 10S-RS
GE PARALLEL DESIGN, INC.
2016-07-15
NA - 8L-RS
GE PARALLEL DESIGN, INC.
2016-07-15
NA - 7S-RS
GE PARALLEL DESIGN, INC.
2016-05-31
NA - 4C
GE PARALLEL DESIGN, INC.
2016-07-15
NA - M4S
GE PARALLEL DESIGN, INC.
2016-07-15
NA - 7S
GE PARALLEL DESIGN, INC.
2016-07-15
NA - 3V
GE PARALLEL DESIGN, INC.
2016-07-15
NA - 5CS
GE PARALLEL DESIGN, INC.
2016-07-15
NA - 3S
GE PARALLEL DESIGN, INC.
2016-07-15
NA - 3.5C
GE PARALLEL DESIGN, INC.
2016-07-15
NA - i12L
GE PARALLEL DESIGN, INC.
2016-07-15
NA - 3V-D
GE PARALLEL DESIGN, INC.
2016-07-15
NA - ML4-20-D
GE PARALLEL DESIGN, INC.
2021-11-18
NA - 6Vc-D
GE PARALLEL DESIGN, INC.
2020-08-07
NA - C4-8-D
GE PARALLEL DESIGN, INC.
2016-07-15
NA - 4C-RS
GE PARALLEL DESIGN, INC.
2016-07-15
NA - 4V-D
GE PARALLEL DESIGN, INC.
2016-07-15