510(k) · Cleared

Cleared

GE Logiq I Comapact Ultrasound, GE Logiq E Compact Ultrasound, GE Vivid E Compact Ultrasound

K072797510(k) SpecialCleared Oct 17, 200716-day reviewClass II21 CFR 892.1560

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

General Electric Co. · IYO System, Imaging, Pulsed Echo, Ultrasonic

Cleared on Oct 17, 2007 as substantially equivalent to K050126 (General Electric Co., 2005) after a 16-day review. Its family tree reaches back 6 generations to 1987. 2 of the 671 devices in its family, counting itself, have a Class I recall. 664 later devices descend from it.

Decided: Oct 17, 2007
Review: 16 days
Class: Class II
Product code: IYO
Recalls: None
Predicates: 1

Its longest line of descent runs back 6 generations to K863700 (1987). 664 later devices descend from it, 7 citing it directly. 2 of the 671 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 6 generations backK863700 RT2800(115V)/H4008C and RT2800(220/240V)/H4008CEGeneral Electric Co. · 1987
5 generations backK953752 RT55 Diagnostic Ultrasound SystemGeneral Electric Co. · 1996
4 generations backK012560 GE Logiq A100 MP, Model 2272413General Electric Co. · 2001
3 generations backK014206 LogiqbookGeneral Electric Co. · 2002 · Recalled
2 generations backK032477 GE Logiq BookGeneral Electric Co. · 2003
1 generation backK050126 GE Logiq TwinGeneral Electric Co. · 2005
This deviceK072797 GE Logiq I Comapact Ultrasound, GE Logiq E Compact Ultrasound, GE…General Electric Co. · 2007
Descendant · cites it directly · 605 of its ownK091164 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

Showing 5 of 664 descendants. See all descendants

Descendants cleared per year

2008high 64 (2017) · low 4 (2008)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 664 · See all

K091164GE Venue 40, Model 5324338Ge Medical Systems China Co., Ltd. · 2009 · cites it directly605descendants
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

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−6	K863700	RT2800(115V)/H4008C and RT2800(220/240V)/H4008CE	General Electric Co.	1987	—
−5	K953752	RT55 Diagnostic Ultrasound System	General Electric Co.	1996	—
−4	K012560	GE Logiq A100 MP, Model 2272413	General Electric Co.	2001	—
−3	K014206	Logiqbook	General Electric Co.	2002	1
−2	K032477	GE Logiq Book	General Electric Co.	2003	—
−1	K050126	GE Logiq Twin	General Electric Co.	2005	—
0 (this device)	K072797	GE Logiq I Comapact Ultrasound, GE Logiq E Compact Ultrasound, GE Vivid E…	General Electric Co.	2007	—
+1	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

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2008	4	0
2009	5	0
2010	9	0
2011	13	0
2012	16	0
2013	20	0
2014	29	0
2015	39	0
2016	42	0
2017	64	0
2018	49	0
2019	37	0
2020	57	0
2021	45	0
2022	46	0
2023	38	0
2024	50	0
2025	58	2
2026	43	0

FIG. 1 — Lineage of K072797, 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 IYO device

#1 K243937 Accuro 3Sscore 20.5 · 18 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
*	K050126	GE Logiq Twin Our reading of the summary gave K051126, FDA’s number for Cardioscope Sonoplus 3000 (Pulsonic Ag, Medical Technology). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “GE LOGIQ-i/e & Vivid-e Compact Ultrasound”.	General Electric Co.	2005	—

What descends from it? (664)

See all 664

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

Number	Device	Applicant	Decided	Descendants
K091164	GE Venue 40, Model 5324338	Ge Medical Systems China Co., Ltd.	2009	605
K091374	GE Logiq I/E & Vivid E Compact Ultrasound	Ge Medical Systems China Co., Ltd.	2009	521
K080640	M5 Diagnostic Ultrasound System	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	2008	182
K083001	M5 Diagnostic Ultrasound System	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	2008	179
K100830	M7/M7T Diagnostic Ultrasound System	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	2010	138
K092756	GE Vscan Compact Diagnostic Ultrasound System	Ge Vingmed Ultrasound AS	2009	130
K102104	GE Vivid P3 Diagnostic Ultrasound Imaging System	Wipro GE Healthcare Private, Ltd.	2010	1

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 20 years and passes through 1 company; a new generation was cleared every 2.7 years on median.
1 of the 6 ancestors has a recall of any class.
Of its descendants, K091164 (Ge Medical Systems China Co., Ltd., 2009) has gone furthest, with 605 descendants of its own.

How does its category compare?

All IYO devices

IYO System, Imaging, Pulsed Echo, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

FDA decisions per year · IYO

7in 2025

2007high 20 (2007) · low 5 (2022)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · IYO

171in 2025

2007high 220 (2024) · low 17 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · IYO

1in 2022

2007high 11 (2021) · low 0 (2011)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · IYO

485in 2025

2007high 640 (2024) · low 20 (2008)2025

MAUDE reports naming product code IYO, 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	20	17	4	39
2008	14	36	5	20
2009	13	79	9	27
2010	15	113	8	20
2011	11	69	0	58
2012	15	68	2	78
2013	17	50	3	436
2014	14	63	2	304
2015	19	46	1	268
2016	10	36	0	254
2017	19	72	0	238
2018	14	56	1	368
2019	13	59	1	537
2020	11	57	0	498
2021	15	64	11	617
2022	5	190	1	511
2023	11	177	0	527
2024	10	220	0	640
2025	7	171	0	485
2026	10	139	1	—

What is it indicated for?

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

Read the full statement (156 words)

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

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K072797 · printed Nov 4, 2026

Cite this page

510(k) Report. “K072797: GE Logiq I Comapact Ultrasound, GE Logiq E Compact Ultrasound, GE Vivid E Compact Ultrasound.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K072797

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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