510(k) · Cleared

Cleared

GE Logiq I/E & Vivid E Compact Ultrasound

K091374510(k) TraditionalCleared May 26, 200915-day reviewClass II21 CFR 892.1560

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Ge Medical Systems China Co., Ltd. · IYO System, Imaging, Pulsed Echo, Ultrasonic

Cleared on May 26, 2009 as substantially equivalent to K072797 (General Electric Co., 2007) and 1 other predicate after a 15-day review. Its family tree reaches back 8 generations to 1987. 521 later devices descend from it.

Decided: May 26, 2009
Review: 15 days
Class: Class II
Product code: IYO
Recalls: None
Predicates: 2

Its longest line of descent runs back 8 generations to K863700 (1987). 521 later devices descend from it, 4 citing it directly.

By dateBy generation

Root · 8 generations backK863700 RT2800(115V)/H4008C and RT2800(220/240V)/H4008CEGeneral Electric Co. · 1987
7 generations backK953752 RT55 Diagnostic Ultrasound SystemGeneral Electric Co. · 1996
6 generations backK012560 GE Logiq A100 MP, Model 2272413General Electric Co. · 2001
5 generations backK014206 LogiqbookGeneral Electric Co. · 2002 · Recalled
4 generations backK032477 GE Logiq BookGeneral Electric Co. · 2003
3 generations backK050126 GE Logiq TwinGeneral Electric Co. · 2005
2 generations backK072797 GE Logiq I Comapact Ultrasound, GE Logiq E Compact Ultrasound, GE…General Electric Co. · 2007
1 generation backK091164 GE Venue 40, Model 5324338Ge Medical Systems China Co., Ltd. · 2009
This deviceK091374 GE Logiq I/E & Vivid E Compact UltrasoundGe Medical Systems China Co., Ltd. · 2009
Descendant · cites it directly · 511 of its ownK102256 GE Logiq I/E & Vivid E Compact Diagnostic UltrasoundGe Medical Systems China Co., Ltd. · 2010
Descendant · 2 generations on · 469 of its ownK113690 GE Logiq I, Logiq E and Vivid EGE Healthcare · 2011 · Recalled
Descendant · 3 generations on · 323 of its ownK123564 Logiq E9 Diagnostic Ultrasound SystemGE Healthcare · 2012 · Recalled
Descendant · 3 generations on · 295 of its ownK120741 Voluson S6, Voluson S8GE Healthcare · 2012
Descendant · 4 generations on · 270 of its ownK131267 Voluson E6/E8/E8EXPERT/E8EXPERT Limited Edition/E10GE Healthcare · 2013

Showing 5 of 521 descendants. See all descendants

Descendants cleared per year

2010high 49 (2020) · low 2 (2010)2026

Most influential descendants

Showing 5 of 521 · See all

K102256GE Logiq I/E & Vivid E Compact Diagnostic UltrasoundGe Medical Systems China Co., Ltd. · 2010 · cites it directly511descendants
K113690GE Logiq I, Logiq E and Vivid EGE Healthcare · 2011 · 2 generations on469descendants
K123564Logiq E9 Diagnostic Ultrasound SystemGE Healthcare · 2012 · 3 generations on323descendants
K120741Voluson S6, Voluson S8GE Healthcare · 2012 · 3 generations on295descendants
K131267Voluson E6/E8/E8EXPERT/E8EXPERT Limited Edition/E10GE Healthcare · 2013 · 4 generations on270descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−8	K863700	RT2800(115V)/H4008C and RT2800(220/240V)/H4008CE	General Electric Co.	1987	—
−7	K953752	RT55 Diagnostic Ultrasound System	General Electric Co.	1996	—
−6	K012560	GE Logiq A100 MP, Model 2272413	General Electric Co.	2001	—
−5	K014206	Logiqbook	General Electric Co.	2002	1
−4	K032477	GE Logiq Book	General Electric Co.	2003	—
−3	K050126	GE Logiq Twin	General Electric Co.	2005	—
−2	K072797	GE Logiq I Comapact Ultrasound, GE Logiq E Compact Ultrasound, GE Vivid E…	General Electric Co.	2007	—
−1	K091164	GE Venue 40, Model 5324338	Ge Medical Systems China Co., Ltd.	2009	—
0 (this device)	K091374	GE Logiq I/E & Vivid E Compact Ultrasound	Ge Medical Systems China Co., Ltd.	2009	—
+1	K102256	GE Logiq I/E & Vivid E Compact Diagnostic Ultrasound	Ge Medical Systems China Co., Ltd.	2010	—
+2	K113690	GE Logiq I, Logiq E and Vivid E	GE Healthcare	2011	1
+3	K123564	Logiq E9 Diagnostic Ultrasound System	GE Healthcare	2012	1
+3	K120741	Voluson S6, Voluson S8	GE Healthcare	2012	—
+4	K131267	Voluson E6/E8/E8EXPERT/E8EXPERT Limited Edition/E10	GE Healthcare	2013	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2010	2	0
2011	8	0
2012	15	0
2013	16	0
2014	25	0
2015	28	0
2016	34	0
2017	45	0
2018	43	0
2019	34	0
2020	49	0
2021	36	0
2022	40	0
2023	33	0
2024	43	0
2025	42	0
2026	28	0

FIG. 1 — Lineage of K091374, 1987–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in IYO? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new IYO device

#1 K243937 Accuro 3Sscore 20.5 · 18 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (2)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K072797	GE Logiq I Comapact Ultrasound, GE Logiq E Compact Ultrasound, GE Vivid E Compact… Summary page 1 …N Diagnostic Ultrasonic Transducer, 21 CFR 892.1 570, 90-ITX 3. Marketed Device: GE LOGIQ-i/e & Vivid-e Compact Ultrasound, 510(k) No: K072797 (90-IYO/IYN/ITX) A device currently in commercial distribution. GE Venue 40…	General Electric Co.	2007	—
*	K091164	GE Venue 40, Model 5324338 Summary page 1 …: K072797 (90-IYO/IYN/ITX) A device currently in commercial distribution. GE Venue 40 Compact Ultrasound, 510(k) No: K091 164 (90-IYO/IYN/ITX) A device currently cleared and starting to commercial distribution. 4. Device Descript…	Ge Medical Systems China Co., Ltd.	2009	—

Also cleared against K072797: 6 other devices →

What descends from it? (521)

See all 521

4 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K102256	GE Logiq I/E & Vivid E Compact Diagnostic Ultrasound	Ge Medical Systems China Co., Ltd.	2010	511
K102113	GE Venue 40 Compact Diagnostic Ultrasound	Ge Medical Systems China Co., Ltd.	2010	161
K103677	M7/M7T Diagnostic Ultrasound System	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	2011	123
K110199	DC-T6 Diagnostic Ultrasound System	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	2011	117

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 22 years and passes through 2 companies; a new generation was cleared every 1.8 years on median.
1 of the 8 ancestors has a recall of any class.
Of its descendants, K102256 (Ge Medical Systems China Co., Ltd., 2010) has gone furthest, with 511 descendants of its own.
6 other devices also cite its predicate K072797.

How does its category compare?

All IYO devices

IYO System, Imaging, Pulsed Echo, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.

FDA decisions per year · IYO

7in 2025

2007high 20 (2007) · low 5 (2022)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · IYO

171in 2025

2007high 220 (2024) · low 17 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · IYO

1in 2022

2007high 11 (2021) · low 0 (2011)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · IYO

485in 2025

2007high 640 (2024) · low 20 (2008)2025

MAUDE reports naming product code IYO, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	20	17	4	39
2008	14	36	5	20
2009	13	79	9	27
2010	15	113	8	20
2011	11	69	0	58
2012	15	68	2	78
2013	17	50	3	436
2014	14	63	2	304
2015	19	46	1	268
2016	10	36	0	254
2017	19	72	0	238
2018	14	56	1	368
2019	13	59	1	537
2020	11	57	0	498
2021	15	64	11	617
2022	5	190	1	511
2023	11	177	0	527
2024	10	220	0	640
2025	7	171	0	485
2026	10	139	1	—

What is it indicated for?

The LOGIQ i/e & Vivid e is a general purpose ultrasound system intended for use by a qualified physician for evaluation by ultrasound imaging or fluid flow analysis of the human body. Specific clinical applications and exam types include: Fetal/OB; Abdominal (GYN & Urology); Pediatric; Small Organ (breast, testes, thyroid); Neonatal and Adult Cephalic; Cardiac (adult & pediatric); Peripheral Vascular; Intra-operative (abdominal, thoracic and PV), Musculo-skeletal Conventional & Superficial, Transrectal and Transvaginal, and Thoracic/Pleural for motion/sliding and fluid detection.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K091374 · printed Nov 4, 2026

Cite this page

510(k) Report. “K091374: GE Logiq I/E & Vivid E Compact Ultrasound.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091374

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026