510(k) · Cleared

Cleared

LOGIQ 500

K010329510(k) SpecialCleared Mar 1, 200127-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 Mar 1, 2001 after a 27-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 717 later devices descend from it.

Decided: Mar 1, 2001
Review: 27 days
Class: Class II
Product code: IYN
Recalls: None
Predicates: 0

717 later devices descend from it, 6 citing it directly.

This deviceK010329 LOGIQ 500General Electric Co. · 2001
Descendant · cites it directly · 657 of its ownK014097 GE Logiq 5GE Medical Systems · 2002 · Recalled
Descendant · 2 generations on · 654 of its ownK032974 GE Logiq 5 Pro or ExpertGeneral Electric Co. · 2003
Descendant · 3 generations on · 653 of its ownK060993 GE Logiq P5 and A5General Electric Co. · 2006
Descendant · cites it directly · 631 of its ownK032182 GE Logiq 7, Model 2354858General Electric Co. · 2003
Descendant · cites it directly · 630 of its ownK041813 GE Logiq 7 Ultrasound BT04Ge Medical Systems Ultrasound and Primary Care Dia · 2004

Showing 5 of 717 descendants. See all descendants

Descendants cleared per year

2002high 66 (2017) · low 1 (2006)2026

Most influential descendants

Showing 5 of 717 · See all

K014097GE Logiq 5GE Medical Systems · 2002 · cites it directly657descendants
K032974GE Logiq 5 Pro or ExpertGeneral Electric Co. · 2003 · 2 generations on654descendants
K060993GE Logiq P5 and A5General Electric Co. · 2006 · 3 generations on653descendants
K032182GE Logiq 7, Model 2354858General Electric Co. · 2003 · cites it directly631descendants
K041813GE Logiq 7 Ultrasound BT04Ge Medical Systems Ultrasound and Primary Care Dia · 2004 · cites it directly630descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K010329	LOGIQ 500	General Electric Co.	2001	—
+1	K014097	GE Logiq 5	GE Medical Systems	2002	1
+2	K032974	GE Logiq 5 Pro or Expert	General Electric Co.	2003	—
+3	K060993	GE Logiq P5 and A5	General Electric Co.	2006	—
+1	K032182	GE Logiq 7, Model 2354858	General Electric Co.	2003	—
+1	K041813	GE Logiq 7 Ultrasound BT04	Ge Medical Systems Ultrasound and Primary Care Dia	2004	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	2	0
2003	2	0
2004	2	0
2005	2	0
2006	1	0
2007	3	0
2008	3	0
2009	7	0
2010	15	0
2011	20	0
2012	29	0
2013	28	0
2014	41	0
2015	40	0
2016	46	0
2017	66	0
2018	55	0
2019	41	0
2020	56	0
2021	39	0
2022	48	0
2023	42	0
2024	46	0
2025	50	0
2026	33	0

FIG. 1 — Lineage of K010329, 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? (717)

See all 717

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

Number	Device	Applicant	Decided	Descendants
K014097	GE Logiq 5	GE Medical Systems	2002	657
K032182	GE Logiq 7, Model 2354858	General Electric Co.	2003	631
K041813	GE Logiq 7 Ultrasound BT04	Ge Medical Systems Ultrasound and Primary Care Dia	2004	630
K073408	GE Logiq BT08 Diagnostic Ultrasound System	Ge Medical Systems Ultrasound and Primary Care Dia	2007	628
K042369	Sonoscape Ultrasound System Ssi-1000/Ssi-5000	Sonoscape Company Limited	2004	40
K052042	Sonoscape Ssi-1000/Ssi-5000 Ultrasound Transducers	Sonoscape Company Limited	2005	33

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, K014097 (GE Medical Systems, 2002) has gone furthest, with 657 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/K010329 · printed Nov 4, 2026

Cite this page

510(k) Report. “K010329: LOGIQ 500.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K010329

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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