510(k) · Cleared

Cleared

GE Logiq 5 Pro or Expert

K032974510(k) SpecialCleared Oct 21, 200327-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

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

Cleared on Oct 21, 2003 as substantially equivalent to K014097 (GE Medical Systems, 2002) after a 27-day review. Its family tree reaches back 2 generations to 2001. 654 later devices descend from it.

Decided: Oct 21, 2003
Review: 27 days
Class: Class II
Product code: IYN
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K010329 (2001). 654 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 2 generations backK010329 LOGIQ 500General Electric Co. · 2001
1 generation backK014097 GE Logiq 5GE Medical Systems · 2002 · Recalled
This deviceK032974 GE Logiq 5 Pro or ExpertGeneral Electric Co. · 2003
Descendant · cites it directly · 653 of its ownK060993 GE Logiq P5 and A5General Electric Co. · 2006
Descendant · 2 generations on · 584 of its ownK080935 Sonix MDP Ultrasound ScannerUltrasonix Medical Corporation · 2008
Descendant · 2 generations on · 582 of its ownK083095 Sonixtouch Ultrasound SystemUltrasonix Medical Corporation · 2008
Descendant · 3 generations on · 569 of its ownK092271 GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3…GE Healthcare · 2009 · Recalled
Descendant · 4 generations on · 472 of its ownK110943 Logiq E9GE Healthcare · 2011 · Recalled

Showing 5 of 654 descendants. See all descendants

Descendants cleared per year

2006high 62 (2017) · low 1 (2006)2026

Most influential descendants

Showing 5 of 654 · See all

K060993GE Logiq P5 and A5General Electric Co. · 2006 · cites it directly653descendants
K080935Sonix MDP Ultrasound ScannerUltrasonix Medical Corporation · 2008 · 2 generations on584descendants
K083095Sonixtouch Ultrasound SystemUltrasonix Medical Corporation · 2008 · 2 generations on582descendants
K092271GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4GE Healthcare · 2009 · 3 generations on569descendants
K110943Logiq E9GE Healthcare · 2011 · 4 generations on472descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K010329	LOGIQ 500	General Electric Co.	2001	—
−1	K014097	GE Logiq 5	GE Medical Systems	2002	1
0 (this device)	K032974	GE Logiq 5 Pro or Expert	General Electric Co.	2003	—
+1	K060993	GE Logiq P5 and A5	General Electric Co.	2006	—
+2	K080935	Sonix MDP Ultrasound Scanner	Ultrasonix Medical Corporation	2008	—
+2	K083095	Sonixtouch Ultrasound System	Ultrasonix Medical Corporation	2008	—
+3	K092271	GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4	GE Healthcare	2009	1
+4	K110943	Logiq E9	GE Healthcare	2011	2

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2006	1	0
2007	1	0
2008	2	0
2009	4	0
2010	11	0
2011	17	0
2012	25	0
2013	25	0
2014	37	0
2015	38	0
2016	40	0
2017	62	0
2018	50	0
2019	37	0
2020	54	0
2021	38	0
2022	45	0
2023	39	0
2024	46	0
2025	49	0
2026	33	0

FIG. 1 — Lineage of K032974, 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

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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
*	K014097	GE Logiq 5	GE Medical Systems	2002	1

Also cleared against K014097: 1 other device →

What descends from it? (654)

See all 654

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

Number	Device	Applicant	Decided	Descendants
K060993	GE Logiq P5 and A5	General Electric Co.	2006	653
K103583	DC-7 Diagnostic Ultrasound System	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	2010	123

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 2 years and passes through 2 companies; a new generation was cleared every 1.8 years on median.
1 of the 2 ancestors has a recall of any class.
Of its descendants, K060993 (General Electric Co., 2006) has gone furthest, with 653 descendants of its own.
1 other device also cites its predicate K014097.

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 Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transesophageal; Transrectal; Transvaginal; and Intraoperative (abdominal, thoracic, vascular and neurological).

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K032974 · printed Nov 4, 2026

Cite this page

510(k) Report. “K032974: GE Logiq 5 Pro or Expert.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K032974

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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