510(k) · Cleared

Cleared

LOGIQ E9, LOGIQ E9 XDClear 2.0

K163077510(k) SpecialCleared Nov 17, 201614-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 Diagnostics · IYN System, Imaging, Pulsed Doppler, Ultrasonic

Cleared on Nov 17, 2016 as substantially equivalent to K152309 (GE Medical Systems Ultrasound and Primary Care Diagnostics, 2015) after a 14-day review. Its family tree reaches back 18 generations to 1995. 73 later devices descend from it.

Decided: Nov 17, 2016
Review: 14 days
Class: Class II
Product code: IYN
Recalls: None
Predicates: 1

Its longest line of descent runs back 18 generations to K935595 (1995). 150 ancestors in all, the oldest K863700 (1987). 73 later devices descend from it, 5 citing it directly.

By dateBy generation

Root · 18 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
14 generations between
3 generations backK123564 Logiq E9 Diagnostic Ultrasound SystemGE Healthcare · 2012 · Recalled
2 generations backK131514 GE Vivid E9 Diagnostic Ultrasound Imaging SystemGe Vingmed Ultrasound AS · 2013 · Recalled
1 generation backK152309 LOGIQ E9, LOGIQ E9 XDClear 2.0GE Medical Systems Ultrasound and Primary Care Diagnostics · 2015 · Recalled
This deviceK163077 LOGIQ E9, LOGIQ E9 XDClear 2.0GE Medical Systems Ultrasound and Primary Care Diagnostics · 2016
Descendant · cites it directly · 38 of its ownK173555 Logiq E10GE Healthcare · 2017 · Recalled
Descendant · cites it directly · 35 of its ownK170823 Vivid E80, Vivid E90, Vivid E95GE Medical Systems Ultrasound and Primary Care Diagnostics · 2017 · Recalled
Descendant · 2 generations on · 20 of its ownK173341 Vivid E80, Vivid E90, Vivid E95GE Medical Systems · 2017 · Recalled
Descendant · 2 generations on · 17 of its ownK181985 Voluson E6, Voluson E8, Voluson E10GE Healthcare · 2018 · Recalled
Descendant · 3 generations on · 13 of its ownK181685 Vivid E80, Vivid E90, Vivid E95GE Medical Systems Ultrasound and Primary Care Diagnostics · 2018

Show all 18 generations

Root · 18 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
17 generations backK973767 Harmonic Imaging with ContrastAcuson Corp. · 1997
16 generations backK022567 Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002
15 generations backK032114 Sequoia 8.0 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2003
14 generations backK041319 Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004
13 generations backK042770 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
12 generations backK050240 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
11 generations backK052894 Sonoline G60 S Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
10 generations backK063138 Modification to Acuson Antares Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006
9 generations backK063803 Acuson Antares Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007 · Recalled
8 generations backK072786 Acuson S2000 Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2007
7 generations backK083095 Sonixtouch Ultrasound SystemUltrasonix Medical Corporation · 2008
6 generations backK092271 GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3…GE Healthcare · 2009 · Recalled
5 generations backK110943 Logiq E9GE Healthcare · 2011 · Recalled
4 generations backK113690 GE Logiq I, Logiq E and Vivid EGE Healthcare · 2011 · Recalled
3 generations backK123564 Logiq E9 Diagnostic Ultrasound SystemGE Healthcare · 2012 · Recalled
2 generations backK131514 GE Vivid E9 Diagnostic Ultrasound Imaging SystemGe Vingmed Ultrasound AS · 2013 · Recalled
1 generation backK152309 LOGIQ E9, LOGIQ E9 XDClear 2.0GE Medical Systems Ultrasound and Primary Care Diagnostics · 2015 · Recalled
This deviceK163077 LOGIQ E9, LOGIQ E9 XDClear 2.0GE Medical Systems Ultrasound and Primary Care Diagnostics · 2016

Showing 5 of 73 descendants. See all descendants

Descendants cleared per year

2017high 11 (2020) · low 3 (2024)2026

Most influential descendants

Showing 5 of 73 · See all

K173555Logiq E10GE Healthcare · 2017 · cites it directly38descendants
K170823Vivid E80, Vivid E90, Vivid E95GE Medical Systems Ultrasound and Primary Care Diagnostics · 2017 · cites it directly35descendants
K173341Vivid E80, Vivid E90, Vivid E95GE Medical Systems · 2017 · 2 generations on20descendants
K181985Voluson E6, Voluson E8, Voluson E10GE Healthcare · 2018 · 2 generations on17descendants
K181685Vivid E80, Vivid E90, Vivid E95GE Medical Systems Ultrasound and Primary Care Diagnostics · 2018 · 3 generations on13descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−18	K935595	Acuson Model 3001	Acuson Corp.	1995	—
−17	K973767	Harmonic Imaging with Contrast	Acuson Corp.	1997	—
−16	K022567	Sequoia Signature II Diagnostic Ultrasound System	Acuson Corp.	2002	—
−15	K032114	Sequoia 8.0 Diagnostic Ultrasound System	Siemens Medical Solutions USA, Inc.	2003	—
−14	K041319	Sequoia Diagnostic Ultrasound System	Siemens Medical Solutions USA, Inc.	2004	—
−13	K042770	Modification to Acuson CV70 Cardiovascular System	Siemens Medical Solutions USA, Inc.	2004	1
−12	K050240	Modification to Acuson CV70 Cardiovascular System	Siemens Medical Solutions USA, Inc.	2005	1
−11	K052894	Sonoline G60 S Ultrasound System	Siemens Medical Solutions USA, Inc.	2005	1
−10	K063138	Modification to Acuson Antares Ultrasound System	Siemens Medical Solutions USA, Inc.	2006	—
−9	K063803	Acuson Antares Diagnostic Ultrasound System	Siemens Medical Solutions USA, Inc., Ultrasound DI	2007	9
−8	K072786	Acuson S2000 Ultrasound System	Siemens Medical Solutions USA, Inc.	2007	—
−7	K083095	Sonixtouch Ultrasound System	Ultrasonix Medical Corporation	2008	—
−6	K092271	GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4	GE Healthcare	2009	1
−5	K110943	Logiq E9	GE Healthcare	2011	2
−4	K113690	GE Logiq I, Logiq E and Vivid E	GE Healthcare	2011	1
−3	K123564	Logiq E9 Diagnostic Ultrasound System	GE Healthcare	2012	1
−2	K131514	GE Vivid E9 Diagnostic Ultrasound Imaging System	Ge Vingmed Ultrasound AS	2013	2
−1	K152309	LOGIQ E9, LOGIQ E9 XDClear 2.0	GE Medical Systems Ultrasound and Primary Care Diagnostics	2015	1
0 (this device)	K163077	LOGIQ E9, LOGIQ E9 XDClear 2.0	GE Medical Systems Ultrasound and Primary Care Diagnostics	2016	—
+1	K173555	Logiq E10	GE Healthcare	2017	2
+1	K170823	Vivid E80, Vivid E90, Vivid E95	GE Medical Systems Ultrasound and Primary Care Diagnostics	2017	3
+2	K173341	Vivid E80, Vivid E90, Vivid E95	GE Medical Systems	2017	3
+2	K181985	Voluson E6, Voluson E8, Voluson E10	GE Healthcare	2018	1
+3	K181685	Vivid E80, Vivid E90, Vivid E95	GE Medical Systems Ultrasound and Primary Care Diagnostics	2018	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1987	1	0
1989	1	0
1992	1	0
1994	4	0
1995	5	0
1996	1	0
1997	6	0
1998	2	0
1999	7	0
2000	7	0
2001	7	0
2002	11	0
2003	12	0
2004	14	0
2005	10	0
2006	8	0
2007	5	0
2008	5	0
2009	5	0
2010	7	0
2011	3	0
2012	7	0
2013	2	0
2014	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2017	5	0
2018	5	0
2019	5	0
2020	11	0
2021	7	0
2022	10	0
2023	7	0
2024	3	0
2025	10	0
2026	10	0

FIG. 1 — Lineage of K163077, 1995–2026Source: 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
*	K152309	LOGIQ E9, LOGIQ E9 XDClear 2.0 Summary page 40 …c Pulsed Echo Imaging System, 21 CFR 892.1560, 90-IYO Product Code: Diagnostic Ultrasound Transducer, 21 CFR 892.1570, 90-ITX Predicate Device(s): K152309 LOGIQ E9 Diagnostic Ultrasound System Device Description: The LOGIQ E9 is a full featured, general purpose diagnostic…	GE Medical Systems Ultrasound and Primary Care Diagnostics	2015	1

Also cleared against K152309: 3 other devices →

What descends from it? (73)

See all 73

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

Number	Device	Applicant	Decided	Descendants
K173555	Logiq E10	GE Healthcare	2017	38
K170823	Vivid E80, Vivid E90, Vivid E95	GE Medical Systems Ultrasound and Primary Care Diagnostics	2017	35
K170878	Vivid S60N, Vivid S70N	GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC	2017	10
K182450	Vivid S60N, Vivid S70N	GE Medical Systems Ultrasound and Primary Care Diagnostics	2018	9
K171891	ZS3 Ultrasound System, z.one pro Ultrasound System	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	2017	4

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 21 years and passes through 7 companies; a new generation was cleared every 12 months on median.
49 of the 150 ancestors have a recall of any class.
Of its descendants, K173555 (GE Healthcare, 2017) has gone furthest, with 38 descendants of its own.
3 other devices also cite its predicate K152309.

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. 2016, 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 device is intended for use by a qualified physician for ultrasound evaluation of Fetal; Abdominal; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transrectal; Transvaginal; Transesophageal and Intraoperative (abdominal, thoracic and vascular).

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K163077 · printed Nov 5, 2026

Cite this page

510(k) Report. “K163077: LOGIQ E9, LOGIQ E9 XDClear 2.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K163077

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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