510(k) · Cleared

Cleared

GE Venue 40, Model 5324338

K091164510(k) TraditionalCleared May 5, 200913-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 China Co., Ltd. · IYN System, Imaging, Pulsed Doppler, Ultrasonic

Cleared on May 5, 2009 as substantially equivalent to K072797 (General Electric Co., 2007) after a 13-day review. Its family tree reaches back 7 generations to 1987. 2 of the 613 devices in its family, counting itself, have a Class I recall. 605 later devices descend from it.

Decided: May 5, 2009
Review: 13 days
Class: Class II
Product code: IYN
Recalls: None
Predicates: 1

Its longest line of descent runs back 7 generations to K863700 (1987). 605 later devices descend from it, 2 citing it directly. 2 of the 613 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 7 generations backK863700 RT2800(115V)/H4008C and RT2800(220/240V)/H4008CEGeneral Electric Co. · 1987
6 generations backK953752 RT55 Diagnostic Ultrasound SystemGeneral Electric Co. · 1996
5 generations backK012560 GE Logiq A100 MP, Model 2272413General Electric Co. · 2001
4 generations backK014206 LogiqbookGeneral Electric Co. · 2002 · Recalled
3 generations backK032477 GE Logiq BookGeneral Electric Co. · 2003
2 generations backK050126 GE Logiq TwinGeneral Electric Co. · 2005
1 generation backK072797 GE Logiq I Comapact Ultrasound, GE Logiq E Compact Ultrasound, GE…General Electric Co. · 2007
This deviceK091164 GE Venue 40, Model 5324338Ge Medical Systems China Co., Ltd. · 2009
Descendant · cites it directly · 521 of its ownK091374 GE Logiq I/E & Vivid E Compact UltrasoundGe Medical Systems China Co., Ltd. · 2009
Descendant · 2 generations on · 511 of its ownK102256 GE Logiq I/E & Vivid E Compact Diagnostic UltrasoundGe Medical Systems China Co., Ltd. · 2010
Descendant · 3 generations on · 469 of its ownK113690 GE Logiq I, Logiq E and Vivid EGE Healthcare · 2011 · Recalled
Descendant · 4 generations on · 323 of its ownK123564 Logiq E9 Diagnostic Ultrasound SystemGE Healthcare · 2012 · Recalled
Descendant · 4 generations on · 295 of its ownK120741 Voluson S6, Voluson S8GE Healthcare · 2012

Showing 5 of 605 descendants. See all descendants

Descendants cleared per year

2009high 56 (2025) · low 2 (2009)2026

Class I recalls in this family

K242670 Lumify Diagnostic Ultrasound System7 generations on · 2025
K242519 Lumify Diagnostic Ultrasound System7 generations on · 2025

Most influential descendants

Showing 5 of 605 · See all

K091374GE Logiq I/E & Vivid E Compact UltrasoundGe Medical Systems China Co., Ltd. · 2009 · cites it directly521descendants
K102256GE Logiq I/E & Vivid E Compact Diagnostic UltrasoundGe Medical Systems China Co., Ltd. · 2010 · 2 generations on511descendants
K113690GE Logiq I, Logiq E and Vivid EGE Healthcare · 2011 · 3 generations on469descendants
K123564Logiq E9 Diagnostic Ultrasound SystemGE Healthcare · 2012 · 4 generations on323descendants
K120741Voluson S6, Voluson S8GE Healthcare · 2012 · 4 generations on295descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−7	K863700	RT2800(115V)/H4008C and RT2800(220/240V)/H4008CE	General Electric Co.	1987	—
−6	K953752	RT55 Diagnostic Ultrasound System	General Electric Co.	1996	—
−5	K012560	GE Logiq A100 MP, Model 2272413	General Electric Co.	2001	—
−4	K014206	Logiqbook	General Electric Co.	2002	1
−3	K032477	GE Logiq Book	General Electric Co.	2003	—
−2	K050126	GE Logiq Twin	General Electric Co.	2005	—
−1	K072797	GE Logiq I Comapact Ultrasound, GE Logiq E Compact Ultrasound, GE Vivid E…	General Electric Co.	2007	—
0 (this device)	K091164	GE Venue 40, Model 5324338	Ge Medical Systems China Co., Ltd.	2009	—
+1	K091374	GE Logiq I/E & Vivid E Compact Ultrasound	Ge Medical Systems China Co., Ltd.	2009	—
+2	K102256	GE Logiq I/E & Vivid E Compact Diagnostic Ultrasound	Ge Medical Systems China Co., Ltd.	2010	—
+3	K113690	GE Logiq I, Logiq E and Vivid E	GE Healthcare	2011	1
+4	K123564	Logiq E9 Diagnostic Ultrasound System	GE Healthcare	2012	1
+4	K120741	Voluson S6, Voluson S8	GE Healthcare	2012	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2009	2	0
2010	2	0
2011	9	0
2012	15	0
2013	16	0
2014	29	0
2015	31	0
2016	39	0
2017	51	0
2018	47	0
2019	36	0
2020	55	0
2021	45	0
2022	44	0
2023	37	0
2024	50	0
2025	56	2
2026	41	0

FIG. 1 — Lineage of K091164, 1987–2026Source: 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.

2 devices in this family have a Class I recall. 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
*	K072797	GE Logiq I Comapact Ultrasound, GE Logiq E Compact Ultrasound, GE Vivid E Compact… Summary page 1 …em, 21 CFR 892.1550, 90-IYN Diagnostic Ultrasonic Transducer, 21 CFR 892.1570, 90-ITX 3. Marketed Device: GE LOGIQ e Diagnostic Ultrasound K072797 (90-IYO/IYN/ITX) A device currently in commercial distribution. 4. Device Description: The Venue 40 devi…	General Electric Co.	2007	—

Also cleared against K072797: 6 other devices →

What descends from it? (605)

See all 605

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

Number	Device	Applicant	Decided	Descendants
K091374	GE Logiq I/E & Vivid E Compact Ultrasound	Ge Medical Systems China Co., Ltd.	2009	521
K092756	GE Vscan Compact Diagnostic Ultrasound System	Ge Vingmed Ultrasound AS	2009	130

Has anything in its family been recalled? (2 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

K242670Lumify Diagnostic Ultrasound SystemPhilips Ultrasound · 2025 · 7 generations on · ◆ in the 2025 descendants bar of FIG. 11 Class I recall
K242519Lumify Diagnostic Ultrasound SystemPhilips Ultrasound · 2025 · 7 generations on · ◆ in the 2025 descendants bar of FIG. 11 Class I recall

What does this lineage say?

The line of descent spans 22 years and passes through 2 companies; a new generation was cleared every 1.8 years on median.
1 of the 7 ancestors has a recall of any class.
Of its descendants, K091374 (Ge Medical Systems China Co., Ltd., 2009) has gone furthest, with 521 descendants of its own.
6 other devices also cite its predicate K072797.

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. 2009, this device’s year, is highlighted.

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 Venue 40 is intended for ultrasound imaging, measurement and analysis of the human body for multiple clinical applications including: Fetal/OB; Abdominal (GYN & Urology); Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult & pediatric); Peripheral Vascular; Musculoskeletal Conventional & Superficial; Intraoperative (abdominal, thoracic and peripheral); Thoracic/Pleural for motion and fluid detection and imaging guidance of interventional procedures.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K091164 · printed Nov 6, 2026

Cite this page

510(k) Report. “K091164: GE Venue 40, Model 5324338.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K091164

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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