510(k) · Cleared

Cleared

GE Logiq 7 Ultrasound BT04

K041813510(k) SpecialCleared Jul 23, 200417-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 Ultrasound and Primary Care Dia · IYN System, Imaging, Pulsed Doppler, Ultrasonic

Cleared on Jul 23, 2004 as substantially equivalent to K010329 (General Electric Co., 2001) and 1 other predicate after a 17-day review. Its family tree reaches back 2 generations to 2001. 630 later devices descend from it.

Decided: Jul 23, 2004
Review: 17 days
Class: Class II
Product code: IYN
Recalls: None
Predicates: 2

Its longest line of descent runs back 2 generations to K010329 (2001). 630 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 2 generations backK010329 LOGIQ 500General Electric Co. · 2001
1 generation backK032182 GE Logiq 7, Model 2354858General Electric Co. · 2003
This deviceK041813 GE Logiq 7 Ultrasound BT04Ge Medical Systems Ultrasound and Primary Care Dia · 2004
Descendant · cites it directly · 629 of its ownK052441 GE Logiq 7 Ultrasound BT05General Electric Co. · 2005
Descendant · cites it directly · 628 of its ownK073408 GE Logiq BT08 Diagnostic Ultrasound SystemGe Medical Systems Ultrasound and Primary Care Dia · 2007
Descendant · 2 generations on · 627 of its ownK082185 GE Logiq E9 Diagnostic Ultrasound System, Models 5205000, 5205000-2Ge Medical Systems Ultrasound and Primary Care Dia · 2008 · Recalled
Descendant · 3 generations on · 569 of its ownK092271 GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3…GE Healthcare · 2009 · Recalled
Descendant · 2 generations on · 472 of its ownK110943 Logiq E9GE Healthcare · 2011 · Recalled

Showing 5 of 630 descendants. See all descendants

Descendants cleared per year

2005high 55 (2017) · low 0 (2006)2026

Most influential descendants

Showing 5 of 630 · See all

K052441GE Logiq 7 Ultrasound BT05General Electric Co. · 2005 · cites it directly629descendants
K073408GE Logiq BT08 Diagnostic Ultrasound SystemGe Medical Systems Ultrasound and Primary Care Dia · 2007 · cites it directly628descendants
K082185GE Logiq E9 Diagnostic Ultrasound System, Models 5205000, 5205000-2Ge Medical Systems Ultrasound and Primary Care Dia · 2008 · 2 generations on627descendants
K092271GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4GE Healthcare · 2009 · 3 generations on569descendants
K110943Logiq E9GE Healthcare · 2011 · 2 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	K032182	GE Logiq 7, Model 2354858	General Electric Co.	2003	—
0 (this device)	K041813	GE Logiq 7 Ultrasound BT04	Ge Medical Systems Ultrasound and Primary Care Dia	2004	—
+1	K052441	GE Logiq 7 Ultrasound BT05	General Electric Co.	2005	—
+1	K073408	GE Logiq BT08 Diagnostic Ultrasound System	Ge Medical Systems Ultrasound and Primary Care Dia	2007	—
+2	K082185	GE Logiq E9 Diagnostic Ultrasound System, Models 5205000, 5205000-2	Ge Medical Systems Ultrasound and Primary Care Dia	2008	1
+3	K092271	GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4	GE Healthcare	2009	1
+2	K110943	Logiq E9	GE Healthcare	2011	2

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2005	1	0
2007	1	0
2008	1	0
2009	3	0
2010	5	0
2011	13	0
2012	23	0
2013	25	0
2014	36	0
2015	32	0
2016	43	0
2017	55	0
2018	53	0
2019	38	0
2020	53	0
2021	39	0
2022	45	0
2023	41	0
2024	45	0
2025	47	0
2026	31	0

FIG. 1 — Lineage of K041813, 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? (2)

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 …60, 90-IYO Ultrasonic Pulsed Doppler Imaging System, 21 CFR 892.1550, 90-IYN 3. Marketed Device: GE LOGIQ 7 Diagnostic Ultrasound System K010329/K032182 (IYO/IYN) A device currently in commercial distribution. 4. Device Description: The GE LOGIQ 7…	General Electric Co.	2001	—
*	K032182	GE Logiq 7, Model 2354858 Summary page 1 …YO Ultrasonic Pulsed Doppler Imaging System, 21 CFR 892.1550, 90-IYN 3. Marketed Device: GE LOGIQ 7 Diagnostic Ultrasound System K010329/K032182 (IYO/IYN) A device currently in commercial distribution. 4. Device Description: The GE LOGIQ 7 is a ful…	General Electric Co.	2003	—

Also cleared against K010329: 5 other devices →

What descends from it? (630)

See all 630

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

Number	Device	Applicant	Decided	Descendants
K052441	GE Logiq 7 Ultrasound BT05	General Electric Co.	2005	629
K073408	GE Logiq BT08 Diagnostic Ultrasound System	Ge Medical Systems Ultrasound and Primary Care Dia	2007	628

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 3 years and passes through 2 companies; a new generation was cleared every 2.4 years on median.
None of the 2 ancestors has a recall.
Of its descendants, K052441 (General Electric Co., 2005) has gone furthest, with 629 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?

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

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/K041813 · printed Nov 5, 2026

Cite this page

510(k) Report. “K041813: GE Logiq 7 Ultrasound BT04.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K041813

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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