510(k) · Cleared

Cleared

GE Logiq 9 Model 2375600

K030934510(k) SpecialCleared Apr 17, 200323-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, Inc. · IYN System, Imaging, Pulsed Doppler, Ultrasonic

Cleared on Apr 17, 2003 as substantially equivalent to K011188 (GE Medical Systems, 2001) after a 23-day review. Its family tree reaches back 1 generation to 2001. 433 later devices descend from it.

Decided: Apr 17, 2003
Review: 23 days
Class: Class II
Product code: IYN
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K011188 (2001). 433 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 1 generation backK011188 GE Logiq 9, Model 2188900-XGE Medical Systems · 2001
This deviceK030934 GE Logiq 9 Model 2375600Ge Medical Systems, Inc. · 2003
Descendant · cites it directly · 432 of its ownK032656 GE Logiq 9 Ultrasound BT03/IQ, Model 2375600-XGe Med. Systems Ultrasound & Prim. Care Diag.,Llc · 2003
Descendant · cites it directly · 431 of its ownK040251 GE Logiq 9 Diagnostic Ultrasound System, Model 2404587Ge Med. Systems Ultrasound & Prim. Care Diag.,Llc · 2004
Descendant · cites it directly · 430 of its ownK061129 GE Logiq 9, Models 2188900, 2375600, 2404587 and 5150000General Electric Co. · 2006 · Recalled
Descendant · 2 generations on · 247 of its ownK082098 Sonosite Maxx Series Ultrasound SystemSonosite,Inc. · 2008 · Recalled
Descendant · 3 generations on · 216 of its ownK113156 Sonosite Edge Ultrasound SystemSonosite,Inc. · 2011 · Recalled

Showing 5 of 433 descendants. See all descendants

Descendants cleared per year

2003high 44 (2017) · low 0 (2005)2026

Most influential descendants

Showing 5 of 433 · See all

K032656GE Logiq 9 Ultrasound BT03/IQ, Model 2375600-XGe Med. Systems Ultrasound & Prim. Care Diag.,Llc · 2003 · cites it directly432descendants
K040251GE Logiq 9 Diagnostic Ultrasound System, Model 2404587Ge Med. Systems Ultrasound & Prim. Care Diag.,Llc · 2004 · cites it directly431descendants
K061129GE Logiq 9, Models 2188900, 2375600, 2404587 and 5150000General Electric Co. · 2006 · cites it directly430descendants
K082098Sonosite Maxx Series Ultrasound SystemSonosite,Inc. · 2008 · 2 generations on247descendants
K113156Sonosite Edge Ultrasound SystemSonosite,Inc. · 2011 · 3 generations on216descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K011188	GE Logiq 9, Model 2188900-X	GE Medical Systems	2001	—
0 (this device)	K030934	GE Logiq 9 Model 2375600	Ge Medical Systems, Inc.	2003	—
+1	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	—
+1	K061129	GE Logiq 9, Models 2188900, 2375600, 2404587 and 5150000	General Electric Co.	2006	1
+2	K082098	Sonosite Maxx Series Ultrasound System	Sonosite,Inc.	2008	2
+3	K113156	Sonosite Edge Ultrasound System	Sonosite,Inc.	2011	1

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	1	0
2004	1	0
2006	1	0
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 K030934, 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? (1)

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	—

Also cleared against K011188: 6 other devices →

What descends from it? (433)

See all 433

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

Number	Device	Applicant	Decided	Descendants
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

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?

Its one ancestor has no recall.
Of its descendants, K032656 (Ge Med. Systems Ultrasound & Prim. Care Diag.,Llc, 2003) has gone furthest, with 432 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?

The device is intended for use by a qualified physician for ultrasound evaluation of Fetal; Abdominal; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult ICephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transrectal; Transvaginal; and Intraoperative (abdominal, thoracic, vascular and neurosurgical).

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K030934 · printed Nov 5, 2026

Cite this page

510(k) Report. “K030934: GE Logiq 9 Model 2375600.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K030934

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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