510(k) · Cleared

Cleared

GE Vivid 3 Expert; GE Vivid 3 Pro

K020789510(k) TraditionalCleared Apr 4, 200224-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 Apr 4, 2002 as substantially equivalent to K000695 (Ge Medical Systems, Inc., 2000) after a 24-day review. Its family tree reaches back 1 generation to 2000. 487 later devices descend from it.

Decided: Apr 4, 2002
Review: 24 days
Class: Class II
Product code: IYN
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K000695 (2000). 487 later devices descend from it, 4 citing it directly.

By dateBy generation

Root · 1 generation backK000695 GE Dolphin Diagnostic Ultrasound System, Ultrasonic Pulsed Doppler…Ge Medical Systems, Inc. · 2000
This deviceK020789 GE Vivid 3 Expert; GE Vivid 3 ProGeneral Electric Co. · 2002
Descendant · cites it directly · 412 of its ownK071985 GE Vivid S5 and S6 Diagnostic UltrasoundGeneral Electric Co. · 2007 · Recalled
Descendant · cites it directly · 350 of its ownK033139 GE Marlin UltrasoundGeneral Electric Co. · 2003 · Recalled
Descendant · 2 generations on · 349 of its ownK061525 GE Vivid - IGeneral Electric Co. · 2006 · Recalled
Descendant · 2 generations on · 331 of its ownK092079 Modification to GE Vivid S5 and S6 Diagnostic UltrasoundGe Medical Systems Israel, Ultrasound, Ltd. · 2009 · Recalled
Descendant · 3 generations on · 286 of its ownK082374 Vivid I and Vivid QGe Medical Systems Israel, Ultrasound, Ltd. · 2008 · Recalled

Showing 5 of 487 descendants. See all descendants

Descendants cleared per year

2003high 44 (2017) · low 0 (2004)2026

Most influential descendants

Showing 5 of 487 · See all

K071985GE Vivid S5 and S6 Diagnostic UltrasoundGeneral Electric Co. · 2007 · cites it directly412descendants
K033139GE Marlin UltrasoundGeneral Electric Co. · 2003 · cites it directly350descendants
K061525GE Vivid - IGeneral Electric Co. · 2006 · 2 generations on349descendants
K092079Modification to GE Vivid S5 and S6 Diagnostic UltrasoundGe Medical Systems Israel, Ultrasound, Ltd. · 2009 · 2 generations on331descendants
K082374Vivid I and Vivid QGe Medical Systems Israel, Ultrasound, Ltd. · 2008 · 3 generations on286descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K000695	GE Dolphin Diagnostic Ultrasound System, Ultrasonic Pulsed Doppler Imaging…	Ge Medical Systems, Inc.	2000	—
0 (this device)	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
+1	K033139	GE Marlin Ultrasound	General Electric Co.	2003	1
+2	K061525	GE Vivid - I	General Electric Co.	2006	1
+2	K092079	Modification to GE Vivid S5 and S6 Diagnostic Ultrasound	Ge Medical Systems Israel, Ultrasound, Ltd.	2009	2
+3	K082374	Vivid I and Vivid Q	Ge Medical Systems Israel, Ultrasound, Ltd.	2008	2

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	1	0
2005	1	0
2006	1	0
2007	1	0
2008	2	0
2009	4	0
2010	11	0
2011	12	0
2012	14	0
2013	17	0
2014	12	0
2015	27	0
2016	26	0
2017	44	0
2018	38	0
2019	30	0
2020	40	0
2021	31	0
2022	37	0
2023	27	0
2024	39	0
2025	42	0
2026	30	0

FIG. 1 — Lineage of K020789, 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

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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
*	K000695	GE Dolphin Diagnostic Ultrasound System, Ultrasonic Pulsed Doppler Imaging System	Ge Medical Systems, Inc.	2000	—

What descends from it? (487)

See all 487

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

Number	Device	Applicant	Decided	Descendants
K071985	GE Vivid S5 and S6 Diagnostic Ultrasound	General Electric Co.	2007	412
K033139	GE Marlin Ultrasound	General Electric Co.	2003	350
K101455	Eko 7 Diagnostic Ultrasound System	Medison Co., Ltd.	2010	111
K043139	Uscom 1A	Uscom, Ltd.	2005	0

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?

Its one ancestor has no recall.
Of its descendants, K071985 (General Electric Co., 2007) has gone furthest, with 412 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)	—

What is it indicated for?

The GE Vivid 3 Expert/Pro systems are general purpose ultrasound systems that are specialized for cardiac imaging. Specific clinical uses include cardiac (adult & pediatric); peripheral vascular; transesophageal; abdominal including GYN and urology; fetal; pediatric; small organ including breast, testes, thyroid; adult and neonatal cephalic; intraoperative (abdominal, thoracic, and vascular); musculo-skeletal (conventional and superficial); transvaginal and transrectal.

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/K020789 · printed Nov 4, 2026

Cite this page

510(k) Report. “K020789: GE Vivid 3 Expert; GE Vivid 3 Pro.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K020789

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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