510(k) · Cleared

Recalled · 2004

GE Logiq 5

K014097510(k) SpecialCleared Jan 10, 200229-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

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

Cleared on Jan 10, 2002 as substantially equivalent to K010329 (General Electric Co., 2001) after a 29-day review. Its family tree reaches back 1 generation to 2001. 657 later devices descend from it. It has been recalled once.

Decided: Jan 10, 2002
Review: 29 days
Class: Class II
Product code: IYN
Recalls: 1
Predicates: 1

Its longest line of descent runs back 1 generation to K010329 (2001). 657 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK010329 LOGIQ 500General Electric Co. · 2001
This deviceK014097 GE Logiq 5GE Medical Systems · 2002
Descendant · cites it directly · 654 of its ownK032974 GE Logiq 5 Pro or ExpertGeneral Electric Co. · 2003
Descendant · 2 generations on · 653 of its ownK060993 GE Logiq P5 and A5General Electric Co. · 2006
Descendant · 3 generations on · 584 of its ownK080935 Sonix MDP Ultrasound ScannerUltrasonix Medical Corporation · 2008
Descendant · 3 generations on · 582 of its ownK083095 Sonixtouch Ultrasound SystemUltrasonix Medical Corporation · 2008
Descendant · 4 generations on · 569 of its ownK092271 GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3…GE Healthcare · 2009 · Recalled

Showing 5 of 657 descendants. See all descendants

Descendants cleared per year

2002high 62 (2017) · low 0 (2004)2026

Most influential descendants

Showing 5 of 657 · See all

K032974GE Logiq 5 Pro or ExpertGeneral Electric Co. · 2003 · cites it directly654descendants
K060993GE Logiq P5 and A5General Electric Co. · 2006 · 2 generations on653descendants
K080935Sonix MDP Ultrasound ScannerUltrasonix Medical Corporation · 2008 · 3 generations on584descendants
K083095Sonixtouch Ultrasound SystemUltrasonix Medical Corporation · 2008 · 3 generations on582descendants
K092271GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4GE Healthcare · 2009 · 4 generations on569descendants

View FIG. 1 as a table

Line of descent and top descendants

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

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	1	0
2003	1	0
2006	1	0
2007	2	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 K014097, 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
*	K010329	LOGIQ 500 Summary page 1 …Diagnostic Ultrasound System Ultrasonic Pulsed Echo Imaging System, 21 CFR 892.1560, 90-IYO 3. Marketed Device: GE LOGIQ 7 diagnostic ultrasound system, 510(k) Numbers K010329 currently in commercial distribution. 4. Device Description: The GE LOGIQ 5 is a full featured general purpose diagnostic ultras…	General Electric Co.	2001	—

Also cleared against K010329: 5 other devices →

What descends from it? (657)

See all 657

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

Number	Device	Applicant	Decided	Descendants
K032974	GE Logiq 5 Pro or Expert	General Electric Co.	2003	654
K020263	LOGIQ 3	General Electric Co.	2002	1

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Sep 2, 2004	Not classified	Z-0386-06	Other	The Estimated Fetal Weight (EFW) result will be incorrect if the operator fails to perform the 'end exam' or new patient registration step before starting an EFW measurement procedure on the next patient.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no recall.
Of its descendants, K032974 (General Electric Co., 2003) has gone furthest, with 654 descendants of its own.
5 other devices also cite its predicate K010329.

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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K014097 · printed Nov 6, 2026

Cite this page

510(k) Report. “K014097: GE Logiq 5.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K014097

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026