510(k) · Cleared

Recalled · Class II · 2022

Modification to GE Vivid S5 and S6 Diagnostic Ultrasound

K092079510(k) SpecialCleared Aug 6, 200928-day reviewClass II21 CFR 892.1550Recalls 2

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

Ge Medical Systems Israel, Ultrasound, Ltd. · IYN System, Imaging, Pulsed Doppler, Ultrasonic

Cleared on Aug 6, 2009 as substantially equivalent to K071985 (General Electric Co., 2007) after a 28-day review. Its family tree reaches back 3 generations to 2000. 331 later devices descend from it. It has been recalled 2 times.

Decided: Aug 6, 2009
Review: 28 days
Class: Class II
Product code: IYN
Recalls: 2
Predicates: 1

Its longest line of descent runs back 3 generations to K000695 (2000). 331 later devices descend from it, 4 citing it directly.

By dateBy generation

Root · 3 generations backK000695 GE Dolphin Diagnostic Ultrasound System, Ultrasonic Pulsed Doppler…Ge Medical Systems, Inc. · 2000
2 generations backK020789 GE Vivid 3 Expert; GE Vivid 3 ProGeneral Electric Co. · 2002
1 generation backK071985 GE Vivid S5 and S6 Diagnostic UltrasoundGeneral Electric Co. · 2007 · Recalled
This deviceK092079 Modification to GE Vivid S5 and S6 Diagnostic UltrasoundGe Medical Systems Israel, Ultrasound, Ltd. · 2009
Descendant · cites it directly · 284 of its ownK102388 Vivid I Diagnostic Ultrasound SystemGe Medical System Israel, Ltd. · 2010 · Recalled
Descendant · 2 generations on · 253 of its ownK120201 GE Vivid E9 Diagnostic Ultrasound Imaging SystemGe Vingmed Ultrasound AS · 2012 · Recalled
Descendant · cites it directly · 177 of its ownK102393 Vivid S5 Diagnostic Ultrasound System; Vivid S6 Diagnosticultrasound…Ge Medical System Israel, Ltd. · 2010 · Recalled
Descendant · 2 generations on · 176 of its ownK121063 Vivid S5 Diagnostic Ultrasound System, Vivid S6 Diagnostic…Ge Medical System Israel, Ltd. · 2012 · Recalled
Descendant · cites it directly · 172 of its ownK101324 GE Echopac Model BT10Ge Vingmed Ultrasound AS · 2010

Showing 5 of 331 descendants. See all descendants

Descendants cleared per year

2010high 34 (2022) · low 1 (2011)2026

Most influential descendants

Showing 5 of 331 · See all

K102388Vivid I Diagnostic Ultrasound SystemGe Medical System Israel, Ltd. · 2010 · cites it directly284descendants
K120201GE Vivid E9 Diagnostic Ultrasound Imaging SystemGe Vingmed Ultrasound AS · 2012 · 2 generations on253descendants
K102393Vivid S5 Diagnostic Ultrasound System; Vivid S6 Diagnosticultrasound SystemGe Medical System Israel, Ltd. · 2010 · cites it directly177descendants
K121063Vivid S5 Diagnostic Ultrasound System, Vivid S6 Diagnostic Ultrasound SystemGe Medical System Israel, Ltd. · 2012 · 2 generations on176descendants
K101324GE Echopac Model BT10Ge Vingmed Ultrasound AS · 2010 · cites it directly172descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K000695	GE Dolphin Diagnostic Ultrasound System, Ultrasonic Pulsed Doppler Imaging…	Ge Medical Systems, Inc.	2000	—
−2	K020789	GE Vivid 3 Expert; GE Vivid 3 Pro	General Electric Co.	2002	—
−1	K071985	GE Vivid S5 and S6 Diagnostic Ultrasound	General Electric Co.	2007	2
0 (this device)	K092079	Modification to GE Vivid S5 and S6 Diagnostic Ultrasound	Ge Medical Systems Israel, Ultrasound, Ltd.	2009	—
+1	K102388	Vivid I Diagnostic Ultrasound System	Ge Medical System Israel, Ltd.	2010	2
+2	K120201	GE Vivid E9 Diagnostic Ultrasound Imaging System	Ge Vingmed Ultrasound AS	2012	1
+1	K102393	Vivid S5 Diagnostic Ultrasound System; Vivid S6 Diagnosticultrasound System	Ge Medical System Israel, Ltd.	2010	2
+2	K121063	Vivid S5 Diagnostic Ultrasound System, Vivid S6 Diagnostic Ultrasound System	Ge Medical System Israel, Ltd.	2012	2
+1	K101324	GE Echopac Model BT10	Ge Vingmed Ultrasound AS	2010	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2010	4	0
2011	1	0
2012	5	0
2013	4	0
2014	5	0
2015	13	0
2016	13	0
2017	24	0
2018	29	0
2019	27	0
2020	32	0
2021	28	0
2022	34	0
2023	25	0
2024	34	0
2025	31	0
2026	22	0

FIG. 1 — Lineage of K092079, 2000–2026Source: 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? (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
*	K071985	GE Vivid S5 and S6 Diagnostic Ultrasound Summary page 1 …-IYO Diagnostic Ultrasonic Transducer, 21 CFR 892.1570, 90-ITX 3. Marketed Device: GE Vivid S5 and Vivid S6 Diagnostic Ultrasound System, K071985 currently in commercial distribution. 4. Device Description: The GE Vivid S5 and Vivid S6 are mobile…	General Electric Co.	2007	2
†	K051449	GE Vivid 7 with or Without Suffix	GE Medical Systems	2005	—
†	K032477	GE Logiq Book	General Electric Co.	2003	—
†	K082374	Vivid I and Vivid Q	Ge Medical Systems Israel, Ultrasound, Ltd.	2008	2
†	K011188	GE Logiq 9, Model 2188900-X	GE Medical Systems	2001	—
†	K081921	GE Vivid E9 Ultrasound	General Electric Co.	2008	—
†	K060993	GE Logiq P5 and A5	General Electric Co.	2006	—

Also cleared against K071985: 1 other device →

What descends from it? (331)

See all 331

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

Number	Device	Applicant	Decided	Descendants
K102388	Vivid I Diagnostic Ultrasound System	Ge Medical System Israel, Ltd.	2010	284
K102393	Vivid S5 Diagnostic Ultrasound System; Vivid S6 Diagnosticultrasound System	Ge Medical System Israel, Ltd.	2010	177
K101324	GE Echopac Model BT10	Ge Vingmed Ultrasound AS	2010	172
K102104	GE Vivid P3 Diagnostic Ultrasound Imaging System	Wipro GE Healthcare Private, Ltd.	2010	1

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Nov 10, 2022	Class II	Z-0752-2023	Device Design	Potential for batteries that have not been replaced at 2 years, as recommended in the Service Manual, they can fail or possibly emit smoke, or catch fire.
Nov 10, 2022	Class II	Z-0753-2023	Device Design	Potential for batteries that have not been replaced at 2 years, as recommended in the Service Manual, they can fail or possibly emit smoke, or catch fire.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 9 years and passes through 3 companies; a new generation was cleared every 2.1 years on median.
1 of the 3 ancestors has a recall of any class.
Of its descendants, K102388 (Ge Medical System Israel, Ltd., 2010) has gone furthest, with 284 descendants of its own.
1 other device also cites its predicate K071985.

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?

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

Ultrasound imaging, measurement and analysis of the human body as follows:

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K092079 · printed Nov 4, 2026

Cite this page

510(k) Report. “K092079: Modification to GE Vivid S5 and S6 Diagnostic Ultrasound.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K092079

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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