510(k) · Cleared

Cleared

GE Echopac

K120221510(k) SpecialCleared Mar 30, 201265-day reviewClass II21 CFR 892.2050

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

GE Healthcare · LLZ System, Image Processing, Radiological

Cleared on Mar 30, 2012 as substantially equivalent to K101324 (Ge Vingmed Ultrasound AS, 2010) after a 65-day review. Its family tree reaches back 7 generations to 2001. 170 later devices descend from it.

Decided: Mar 30, 2012
Review: 65 days
Class: Class II
Product code: LLZ
Recalls: None
Predicates: 1

Its longest line of descent runs back 7 generations to K003931 (2001). 12 ancestors in all, the oldest K000695 (2000). 170 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 7 generations backK003931 Vivid 7 with Sonopac, Model FB0008XXGe Medical Systems, Inc. · 2001
6 generations backK031663 GE Vivid 7, Model FC0003XXGeneral Electric Co. · 2003
5 generations backK041552 GE Vivid 7 BT04General Electric Co. · 2004
4 generations backK051449 GE Vivid 7 with or Without SuffixGE Medical Systems · 2005
3 generations backK060542 GE Vivid 7 Model FC008XX, GE Vivid 7 Model FC009XXGeneral Electric Co. · 2006 · Recalled
2 generations backK072952 GE EchopacGeneral Electric Co. · 2007
1 generation backK101324 GE Echopac Model BT10Ge Vingmed Ultrasound AS · 2010
This deviceK120221 GE EchopacGE Healthcare · 2012
Descendant · cites it directly · 167 of its ownK131514 GE Vivid E9 Diagnostic Ultrasound Imaging SystemGe Vingmed Ultrasound AS · 2013 · Recalled
Descendant · 2 generations on · 100 of its ownK152309 LOGIQ E9, LOGIQ E9 XDClear 2.0GE Medical Systems Ultrasound and Primary Care Diagnostics · 2015 · Recalled
Descendant · 2 generations on · 85 of its ownK141093 6VT-D Ultrasound TransducerGe Vingmed Ultrasound AS · 2014
Descendant · 2 generations on · 84 of its ownK142323 Vivid S60 Diagnostic Ultrasound System, Vivid S70 Diagnostic…Ge Medical Systems Israel, Ltd. · 2014 · Recalled
Descendant · 3 generations on · 73 of its ownK163077 LOGIQ E9, LOGIQ E9 XDClear 2.0GE Medical Systems Ultrasound and Primary Care Diagnostics · 2016

Showing 5 of 170 descendants. See all descendants

Descendants cleared per year

2013high 22 (2020) · low 2 (2014)2026

Most influential descendants

Showing 5 of 170 · See all

K131514GE Vivid E9 Diagnostic Ultrasound Imaging SystemGe Vingmed Ultrasound AS · 2013 · cites it directly167descendants
K152309LOGIQ E9, LOGIQ E9 XDClear 2.0GE Medical Systems Ultrasound and Primary Care Diagnostics · 2015 · 2 generations on100descendants
K1410936VT-D Ultrasound TransducerGe Vingmed Ultrasound AS · 2014 · 2 generations on85descendants
K142323Vivid S60 Diagnostic Ultrasound System, Vivid S70 Diagnostic Ultrasound SystemGe Medical Systems Israel, Ltd. · 2014 · 2 generations on84descendants
K163077LOGIQ E9, LOGIQ E9 XDClear 2.0GE Medical Systems Ultrasound and Primary Care Diagnostics · 2016 · 3 generations on73descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−7	K003931	Vivid 7 with Sonopac, Model FB0008XX	Ge Medical Systems, Inc.	2001	—
−6	K031663	GE Vivid 7, Model FC0003XX	General Electric Co.	2003	—
−5	K041552	GE Vivid 7 BT04	General Electric Co.	2004	—
−4	K051449	GE Vivid 7 with or Without Suffix	GE Medical Systems	2005	—
−3	K060542	GE Vivid 7 Model FC008XX, GE Vivid 7 Model FC009XX	General Electric Co.	2006	1
−2	K072952	GE Echopac	General Electric Co.	2007	—
−1	K101324	GE Echopac Model BT10	Ge Vingmed Ultrasound AS	2010	—
0 (this device)	K120221	GE Echopac	GE Healthcare	2012	—
+1	K131514	GE Vivid E9 Diagnostic Ultrasound Imaging System	Ge Vingmed Ultrasound AS	2013	2
+2	K152309	LOGIQ E9, LOGIQ E9 XDClear 2.0	GE Medical Systems Ultrasound and Primary Care Diagnostics	2015	1
+2	K141093	6VT-D Ultrasound Transducer	Ge Vingmed Ultrasound AS	2014	—
+2	K142323	Vivid S60 Diagnostic Ultrasound System, Vivid S70 Diagnostic Ultrasound System	Ge Medical Systems Israel, Ltd.	2014	3
+3	K163077	LOGIQ E9, LOGIQ E9 XDClear 2.0	GE Medical Systems Ultrasound and Primary Care Diagnostics	2016	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2000	1	0
2002	1	0
2007	1	0
2008	1	0
2009	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2013	3	0
2014	2	0
2015	4	0
2016	4	0
2017	10	0
2018	14	0
2019	12	0
2020	22	0
2021	14	0
2022	20	0
2023	15	0
2024	17	0
2025	17	0
2026	16	0

FIG. 1 — Lineage of K120221, 2001–2026Source: 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 LLZ? 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 LLZ device

#1 K230955 syngo Application Softwarescore 21.5 · 11 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
*	K101324	GE Echopac Model BT10 Summary page 1 …reporting Classification Names: 21 CFR 892.2050 Product Code: LLZ Predicate Device(s): K101 324 - GE EchoPAC Device Description: GE EchoPAC provides image processing, annotation, analysis, me…	Ge Vingmed Ultrasound AS	2010	—

Also cleared against K101324: 1 other device →

What descends from it? (170)

See all 170

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

Number	Device	Applicant	Decided	Descendants
K131514	GE Vivid E9 Diagnostic Ultrasound Imaging System	Ge Vingmed Ultrasound AS	2013	167
K173090	Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V2.4	Toshibamedical Systems Corporation	2018	21
K123894	GE Echopac	Ge Vingmed Ultrasound AS	2013	9

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 11 years and passes through 5 companies; a new generation was cleared every 1.5 years on median.
3 of the 12 ancestors have a recall of any class.
Of its descendants, K131514 (Ge Vingmed Ultrasound AS, 2013) has gone furthest, with 167 descendants of its own.
1 other device also cites its predicate K101324.

How does its category compare?

All LLZ devices

LLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.

FDA decisions per year · LLZ

58in 2025

2007high 106 (2011) · low 51 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LLZ

173in 2025

2007high 173 (2025) · low 36 (2007)2026

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

Recalls per year · LLZ

11in 2025

2007high 64 (2013) · low 2 (2019)2026

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

Adverse event reports per year · LLZ

116in 2025

2007high 15,631 (2014) · low 26 (2023)2025

MAUDE reports naming product code LLZ, 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	76	36	20	152
2008	94	52	32	154
2009	70	62	21	145
2010	51	98	17	145
2011	106	79	30	454
2012	82	87	12	266
2013	95	84	64	1,130
2014	78	89	6	15,631
2015	64	90	16	211
2016	82	90	12	290
2017	78	107	5	104
2018	104	105	7	72
2019	74	107	2	88
2020	81	115	6	82
2021	83	116	3	70
2022	65	137	4	28
2023	87	157	8	26
2024	62	131	6	42
2025	58	173	11	116
2026	45	110	14	—

What is it indicated for?

The GE EchoPAC workstation is indicated for diagnostic review and analysis of ultrasound images acquired under various modes of operation including B, M, Color M modes, Color, Power, Pulsed & CW Doppler modes, Coded Pulse, Harmonic and Realtime 3D. Clinical applications include: Fetal; Abdominal; Urology (including prostate); Pediatric; Small Organ (breast, testes, thyroid); Neonatal and Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Transesophageal (TEE); Musculo-skeletal Conventional; Transrectal (TR); Transvaginal (TV); and lntraoperative (abdominal, thoracic, & vascular).

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K120221 · printed Nov 4, 2026

Cite this page

510(k) Report. “K120221: GE Echopac.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K120221

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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