510(k) · Cleared

Recalled · Class II · 2018

GE Logiq 9, Models 2188900, 2375600, 2404587 and 5150000

K061129510(k) SpecialCleared Jun 1, 200638-day reviewClass II21 CFR 892.1550Recalls 1

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

General Electric Co. · IYN System, Imaging, Pulsed Doppler, Ultrasonic

Cleared on Jun 1, 2006 as substantially equivalent to K011188 (GE Medical Systems, 2001) and 3 other predicates after a 38-day review. Its family tree reaches back 4 generations to 2001. 430 later devices descend from it. It has been recalled once.

Decided: Jun 1, 2006
Review: 38 days
Class: Class II
Product code: IYN
Recalls: 1
Predicates: 4

Its longest line of descent runs back 4 generations to K011188 (2001). 430 later devices descend from it, 5 citing it directly.

By dateBy generation

Root · 4 generations backK011188 GE Logiq 9, Model 2188900-XGE Medical Systems · 2001
3 generations backK030934 GE Logiq 9 Model 2375600Ge Medical Systems, Inc. · 2003
2 generations backK032656 GE Logiq 9 Ultrasound BT03/IQ, Model 2375600-XGe Med. Systems Ultrasound & Prim. Care Diag.,Llc · 2003
1 generation backK040251 GE Logiq 9 Diagnostic Ultrasound System, Model 2404587Ge Med. Systems Ultrasound & Prim. Care Diag.,Llc · 2004
This deviceK061129 GE Logiq 9, Models 2188900, 2375600, 2404587 and 5150000General Electric Co. · 2006
Descendant · cites it directly · 247 of its ownK082098 Sonosite Maxx Series Ultrasound SystemSonosite,Inc. · 2008 · Recalled
Descendant · 2 generations on · 216 of its ownK113156 Sonosite Edge Ultrasound SystemSonosite,Inc. · 2011 · Recalled
Descendant · cites it directly · 188 of its ownK072164 DC-6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2007
Descendant · cites it directly · 182 of its ownK080640 M5 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2008
Descendant · 2 generations on · 180 of its ownK081320 DC-3, DC-3T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2008

Showing 5 of 430 descendants. See all descendants

Descendants cleared per year

2007high 44 (2017) · low 1 (2007)2026

Most influential descendants

Showing 5 of 430 · See all

K082098Sonosite Maxx Series Ultrasound SystemSonosite,Inc. · 2008 · cites it directly247descendants
K113156Sonosite Edge Ultrasound SystemSonosite,Inc. · 2011 · 2 generations on216descendants
K072164DC-6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2007 · cites it directly188descendants
K080640M5 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2008 · cites it directly182descendants
K081320DC-3, DC-3T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2008 · 2 generations on180descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K011188	GE Logiq 9, Model 2188900-X	GE Medical Systems	2001	—
−3	K030934	GE Logiq 9 Model 2375600	Ge Medical Systems, Inc.	2003	—
−2	K032656	GE Logiq 9 Ultrasound BT03/IQ, Model 2375600-X	Ge Med. Systems Ultrasound & Prim. Care Diag.,Llc	2003	—
−1	K040251	GE Logiq 9 Diagnostic Ultrasound System, Model 2404587	Ge Med. Systems Ultrasound & Prim. Care Diag.,Llc	2004	—
0 (this device)	K061129	GE Logiq 9, Models 2188900, 2375600, 2404587 and 5150000	General Electric Co.	2006	—
+1	K082098	Sonosite Maxx Series Ultrasound System	Sonosite,Inc.	2008	2
+2	K113156	Sonosite Edge Ultrasound System	Sonosite,Inc.	2011	1
+1	K072164	DC-6 Diagnostic Ultrasound System	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	2007	—
+1	K080640	M5 Diagnostic Ultrasound System	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	2008	—
+2	K081320	DC-3, DC-3T Diagnostic Ultrasound System	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	2008	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2007	1	0
2008	5	0
2009	4	0
2010	8	0
2011	12	0
2012	8	0
2013	15	0
2014	7	0
2015	27	0
2016	26	0
2017	44	0
2018	30	0
2019	31	0
2020	40	0
2021	29	0
2022	36	0
2023	23	0
2024	30	0
2025	33	0
2026	21	0

FIG. 1 — Lineage of K061129, 2001–2026Source: 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 IYN? 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 IYN device

#1 K240850 EPIQ Series Diagnostic Ultrasound Systems…score 32.1 · 24 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) Report

What was it cleared against? (5)

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
*	K011188	GE Logiq 9, Model 2188900-X	GE Medical Systems	2001	—
*	K030934	GE Logiq 9 Model 2375600 Summary page 1 …YO Ultrasonic Pulsed Doppler Imaging System, 21 CFR 892.1550, 90-1IYN 3. Marketed Device: GE LOGOQ 9 Diagnostic Ultrasound System K•01 l188/1<030934/K032656/1Ko40251 A device currently in commercial distribution. 4. Device Description: The GE LOGIO 9 i…	Ge Medical Systems, Inc.	2003	—
*	K032656	GE Logiq 9 Ultrasound BT03/IQ, Model 2375600-X Summary page 1 …Ultrasonic Pulsed Doppler Imaging System, 21 CFR 892.1550, 90-1IYN 3. Marketed Device: GE LOGOQ 9 Diagnostic Ultrasound System K•01 l188/1<030934/K032656/1Ko40251 A device currently in commercial distribution. 4. Device Description: The GE LOGIO 9 is a full…	Ge Med. Systems Ultrasound & Prim. Care Diag.,Llc	2003	—
*	K040251	GE Logiq 9 Diagnostic Ultrasound System, Model 2404587	Ge Med. Systems Ultrasound & Prim. Care Diag.,Llc	2004	—
*	—	GE Logiq 7 Named without a submission number			—

Also cleared against K011188: 6 other devices →

What descends from it? (430)

See all 430

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

Number	Device	Applicant	Decided	Descendants
K082098	Sonosite Maxx Series Ultrasound System	Sonosite,Inc.	2008	247
K072164	DC-6 Diagnostic Ultrasound System	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	2007	188
K080640	M5 Diagnostic Ultrasound System	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	2008	182
K083001	M5 Diagnostic Ultrasound System	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	2008	179
K090912	Digital Ultrasonic Diagnostic Imaging System, Model DP-6900	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	2009	114

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Mar 22, 2018	Class II	Z-2984-2018	Component design/selection	The system side of the power cord may break and expose the electrical conductors leading to the risk of shock.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 5 years and passes through 4 companies; a new generation was cleared every 1.9 years on median.
None of the 4 ancestors has a recall.
Of its descendants, K082098 (Sonosite,Inc., 2008) has gone furthest, with 247 descendants of its own.
6 other devices also cite its predicate K011188.

How does its category compare?

All IYN devices

IYN System, Imaging, Pulsed Doppler, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · IYN

57in 2025

2007high 64 (2017) · low 13 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · IYN

124in 2025

2007high 124 (2025) · low 18 (2008)2026

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

Recalls per year · IYN

10in 2025

2007high 16 (2007) · low 0 (2017)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · IYN

610in 2025

2007high 610 (2025) · low 2 (2008)2025

MAUDE reports naming product code IYN, 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	13	26	16	3
2008	25	18	12	2
2009	18	29	8	9
2010	29	67	10	17
2011	39	46	8	18
2012	43	37	3	20
2013	51	60	8	18
2014	56	39	2	48
2015	54	55	3	116
2016	60	56	2	145
2017	64	83	0	146
2018	59	85	7	85
2019	47	79	0	59
2020	57	72	4	67
2021	46	105	8	213
2022	53	105	10	186
2023	44	115	4	229
2024	50	119	1	266
2025	57	124	10	610
2026	44	107	2 (1)	—

What is it indicated for?

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K061129 · printed Nov 4, 2026

Cite this page

510(k) Report. “K061129: GE Logiq 9, Models 2188900, 2375600, 2404587 and 5150000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K061129

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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