510(k) · Cleared

Cleared

GE Logiq 9, Model 2188900-X

K011188510(k) SpecialCleared May 18, 200130-day reviewClass II21 CFR 892.1550

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

GE Medical Systems · IYN System, Imaging, Pulsed Doppler, Ultrasonic

Cleared on May 18, 2001 after a 30-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 752 later devices descend from it.

Decided: May 18, 2001
Review: 30 days
Class: Class II
Product code: IYN
Recalls: None
Predicates: 0

752 later devices descend from it, 7 citing it directly.

This deviceK011188 GE Logiq 9, Model 2188900-XGE Medical Systems · 2001
Descendant · cites it directly · 683 of its ownK030949 Titan High Resolution Ultrasound SystemSonosite,Inc. · 2003
Descendant · cites it directly · 678 of its ownK043559 Sonosite High-Resolution Diagnostic Ultrasound System (C3 Series)Sonosite,Inc. · 2005 · Recalled
Descendant · 2 generations on · 676 of its ownK053069 Sonosite Micromaxx Diagnostic Ultrasound System (C3 Series)Sonosite,Inc. · 2005 · Recalled
Descendant · 3 generations on · 584 of its ownK080935 Sonix MDP Ultrasound ScannerUltrasonix Medical Corporation · 2008
Descendant · 2 generations on · 583 of its ownK080223 Zura Tee SystemImacor, LLC · 2008 · Recalled

Showing 5 of 752 descendants. See all descendants

Descendants cleared per year

2002high 66 (2017) · low 1 (2002)2026

Most influential descendants

Showing 5 of 752 · See all

K030949Titan High Resolution Ultrasound SystemSonosite,Inc. · 2003 · cites it directly683descendants
K043559Sonosite High-Resolution Diagnostic Ultrasound System (C3 Series)Sonosite,Inc. · 2005 · cites it directly678descendants
K053069Sonosite Micromaxx Diagnostic Ultrasound System (C3 Series)Sonosite,Inc. · 2005 · 2 generations on676descendants
K080935Sonix MDP Ultrasound ScannerUltrasonix Medical Corporation · 2008 · 3 generations on584descendants
K080223Zura Tee SystemImacor, LLC · 2008 · 2 generations on583descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K011188	GE Logiq 9, Model 2188900-X	GE Medical Systems	2001	—
+1	K030949	Titan High Resolution Ultrasound System	Sonosite,Inc.	2003	—
+1	K043559	Sonosite High-Resolution Diagnostic Ultrasound System (C3 Series)	Sonosite,Inc.	2005	4
+2	K053069	Sonosite Micromaxx Diagnostic Ultrasound System (C3 Series)	Sonosite,Inc.	2005	3
+3	K080935	Sonix MDP Ultrasound Scanner	Ultrasonix Medical Corporation	2008	—
+2	K080223	Zura Tee System	Imacor, LLC	2008	1

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	1	0
2003	4	0
2004	2	0
2005	2	0
2006	1	0
2007	3	0
2008	10	0
2009	8	0
2010	14	0
2011	19	0
2012	26	0
2013	29	0
2014	39	0
2015	46	0
2016	51	0
2017	66	0
2018	55	0
2019	41	0
2020	59	0
2021	42	0
2022	49	0
2023	43	0
2024	49	0
2025	56	0
2026	37	0

FIG. 1 — Lineage of K011188, 2001–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (752)

See all 752

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

Number	Device	Applicant	Decided	Descendants
K030949	Titan High Resolution Ultrasound System	Sonosite,Inc.	2003	683
K043559	Sonosite High-Resolution Diagnostic Ultrasound System (C3 Series)	Sonosite,Inc.	2005	678
K030934	GE Logiq 9 Model 2375600	Ge Medical Systems, Inc.	2003	433
K032656	GE Logiq 9 Ultrasound BT03/IQ, Model 2375600-X	Ge Med. Systems Ultrasound & Prim. Care Diag.,Llc	2003	432
K040251	GE Logiq 9 Diagnostic Ultrasound System, Model 2404587	Ge Med. Systems Ultrasound & Prim. Care Diag.,Llc	2004	431
K061129	GE Logiq 9, Models 2188900, 2375600, 2404587 and 5150000	General Electric Co.	2006	430
K022858	Supernova Diagnostic Ultrasound Scanning System	Novasonics, Inc.	2002	134

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?

Of its descendants, K030949 (Sonosite,Inc., 2003) has gone furthest, with 683 descendants of its own.

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)	—

https://510kreport.com/device/K011188 · printed Nov 6, 2026

Cite this page

510(k) Report. “K011188: GE Logiq 9, Model 2188900-X.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K011188

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026