510(k) · Cleared

Cleared

Echonavigator Release 1

K121781510(k) AbbreviatedCleared Oct 26, 2012130-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

Philips Medical Systems Nederland B.V. · LLZ System, Image Processing, Radiological

Cleared on Oct 26, 2012 as substantially equivalent to K111245 (Philips Medical Systems Nederland B.V., 2011) and 1 other predicate after a 130-day review. Its family tree reaches back 9 generations to 1989. 32 later devices descend from it.

Decided: Oct 26, 2012
Review: 130 days
Class: Class II
Product code: LLZ
Recalls: None
Predicates: 2

Its longest line of descent runs back 9 generations to K890348 (1989). 64 ancestors in all, the oldest K852353 (1985). 32 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 9 generations backK890348 LC, Cardiac Positioner #B5078AGeneral Electric Co. · 1989 · Recalled
5 generations between
3 generations backK062650 EP Navigator SoftwarePhilips Medical Systems · 2006
2 generations backK101311 EP Navigator R3Philips Medical Systems North America Co. · 2010
1 generation backK111245 Heartnavigator Release 1Philips Medical Systems Nederland B.V. · 2011
This deviceK121781 Echonavigator Release 1Philips Medical Systems Nederland B.V. · 2012
Descendant · cites it directly · 28 of its ownK172607 Philips EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic…Philips Health Care · 2017 · Recalled
Descendant · 2 generations on · 27 of its ownK181485 EPIQ , EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 50 and Affiniti 70…Philips Ultrasound, Inc. · 2018 · Recalled
Descendant · 3 generations on · 24 of its ownK200304 EPIQ Diagnostic Ultrasound SystemPhilips Ultrasound, Inc. · 2020 · Recalled
Descendant · 4 generations on · 21 of its ownK202216 EPIQ Series Diagnostic Ultrasound SystemsPhilips Ultrasound, Inc. · 2020 · Recalled
Descendant · 3 generations on · 19 of its ownK182857 EPIQ Diagnostic Ultrasound System, EPIQ 5 Diagnostic Ultrasound…Philips Ultrasound, Inc. · 2018 · Recalled

Show all 9 generations

Root · 9 generations backK890348 LC, Cardiac Positioner #B5078AGeneral Electric Co. · 1989 · Recalled
8 generations backK993037 LCV+ Version 2Ge Medical Systems, Inc. · 2000 · Recalled
7 generations backK020055 Philips Integris Allura 9 with FD OptionPhilips Medical Systems · 2002 · Recalled
6 generations backK022899 Philips Integris Allura Flat Detector Release 1.0Philips Medical Systems North America Co. · 2002 · Recalled
5 generations backK031333 Philips Integris Allura Flat Detector Release 1.2Philips Medical Systems North America, Inc. · 2003 · Recalled
4 generations backK031836 Philips Fresco Release 1Philips Medical Systems North America Co. · 2003
3 generations backK062650 EP Navigator SoftwarePhilips Medical Systems · 2006
2 generations backK101311 EP Navigator R3Philips Medical Systems North America Co. · 2010
1 generation backK111245 Heartnavigator Release 1Philips Medical Systems Nederland B.V. · 2011
This deviceK121781 Echonavigator Release 1Philips Medical Systems Nederland B.V. · 2012

Showing 5 of 32 descendants. See all descendants

Descendants cleared per year

2017high 7 (2025) · low 0 (2019)2026

Most influential descendants

Showing 5 of 32 · See all

K172607Philips EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System…Philips Health Care · 2017 · cites it directly28descendants
K181485EPIQ , EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 50 and Affiniti 70 Diagnostic Ultrasound…Philips Ultrasound, Inc. · 2018 · 2 generations on27descendants
K200304EPIQ Diagnostic Ultrasound SystemPhilips Ultrasound, Inc. · 2020 · 3 generations on24descendants
K202216EPIQ Series Diagnostic Ultrasound SystemsPhilips Ultrasound, Inc. · 2020 · 4 generations on21descendants
K182857EPIQ Diagnostic Ultrasound System, EPIQ 5 Diagnostic Ultrasound System, EPIQ 7…Philips Ultrasound, Inc. · 2018 · 3 generations on19descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−9	K890348	LC, Cardiac Positioner #B5078A	General Electric Co.	1989	5
−8	K993037	LCV+ Version 2	Ge Medical Systems, Inc.	2000	6
−7	K020055	Philips Integris Allura 9 with FD Option	Philips Medical Systems	2002	2
−6	K022899	Philips Integris Allura Flat Detector Release 1.0	Philips Medical Systems North America Co.	2002	8
−5	K031333	Philips Integris Allura Flat Detector Release 1.2	Philips Medical Systems North America, Inc.	2003	25
−4	K031836	Philips Fresco Release 1	Philips Medical Systems North America Co.	2003	—
−3	K062650	EP Navigator Software	Philips Medical Systems	2006	—
−2	K101311	EP Navigator R3	Philips Medical Systems North America Co.	2010	—
−1	K111245	Heartnavigator Release 1	Philips Medical Systems Nederland B.V.	2011	—
0 (this device)	K121781	Echonavigator Release 1	Philips Medical Systems Nederland B.V.	2012	—
+1	K172607	Philips EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound…	Philips Health Care	2017	31
+2	K181485	EPIQ , EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 50 and Affiniti 70 Diagnostic…	Philips Ultrasound, Inc.	2018	24
+3	K200304	EPIQ Diagnostic Ultrasound System	Philips Ultrasound, Inc.	2020	3
+4	K202216	EPIQ Series Diagnostic Ultrasound Systems	Philips Ultrasound, Inc.	2020	8
+3	K182857	EPIQ Diagnostic Ultrasound System, EPIQ 5 Diagnostic Ultrasound System, EPIQ 7…	Philips Ultrasound, Inc.	2018	23

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1985	1	0
1987	1	0
1991	1	0
1993	3	0
1994	3	0
1995	3	0
1996	2	0
1997	2	0
1998	3	0
1999	1	0
2000	4	0
2001	5	0
2002	2	0
2003	6	0
2004	9	0
2005	1	0
2006	2	0
2007	1	0
2009	1	0
2011	2	0
2012	2	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2017	1	0
2018	2	0
2020	4	0
2021	2	0
2022	2	0
2023	2	0
2024	5	0
2025	7	0
2026	7	0

FIG. 1 — Lineage of K121781, 1989–2026Source: 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

Get a 510(k) Report

What was it cleared against? (2)

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
*	K111245	Heartnavigator Release 1	Philips Medical Systems Nederland B.V.	2011	—
*	K121223	Qlab with FHN and VPQ Plug-in Summary page 1 …KI 11245 - Jul 29, 2011 Trade names: QLAB with ERTN and VPQ plug-in Manufacturer: Philips 510(k) numbers: K 121223 -May 15, 2012 EchoNavigator Rel. 1 -Page 22 of…	Philips Ultrasound, Inc.	2012	—

Also cleared against K111245: 3 other devices →

What descends from it? (32)

See all 32

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

Number	Device	Applicant	Decided	Descendants
K172607	Philips EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System…	Philips Health Care	2017	28
K200713	EchoNavigator	Philips Medical Systems Nederland B.V.	2020	2

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 23 years and passes through 6 companies; a new generation was cleared every 1.2 years on median.
28 of the 64 ancestors have a recall of any class.
Of its descendants, K172607 (Philips Health Care, 2017) has gone furthest, with 28 descendants of its own.
3 other devices also cite its predicate K111245.

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?

EchoNavigator supports the interventionalist and surgeon in treatments where both live X-ray and live Echo guidance are used. The targeted patient population consists of patients with cardiovascular diseases requiring such a treatment.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K121781 · printed Nov 6, 2026

Cite this page

510(k) Report. “K121781: Echonavigator Release 1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121781

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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