510(k) · Cleared

Recalled · 2010

Sonoline Antares Diagnostic Ultrasound System

K050034510(k) TraditionalCleared Jan 13, 20056-day reviewClass II21 CFR 892.1550Recalls 1

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

Siemens Medical Solutions USA, Inc. · IYN System, Imaging, Pulsed Doppler, Ultrasonic

Cleared on Jan 13, 2005 as substantially equivalent to K001400 (Siemens Medical Solutions USA, Inc., 2000) and 1 other predicate after a 6-day review. Its family tree reaches back 5 generations to 1995. 2 of the 942 devices in its family, counting itself, have a Class I recall. 921 later devices descend from it. It has been recalled once.

Decided: Jan 13, 2005
Review: 6 days
Class: Class II
Product code: IYN
Recalls: 1
Predicates: 2

Its longest line of descent runs back 5 generations to K935595 (1995). 20 ancestors in all, the oldest K921148 (1992). 921 later devices descend from it, 6 citing it directly. 2 of the 942 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 5 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
4 generations backK973767 Harmonic Imaging with ContrastAcuson Corp. · 1997
3 generations backK022567 Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002
2 generations backK032111 Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2003 · Recalled
1 generation backK040060 Sonoline G50 and G60 S Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc. · 2004
This deviceK050034 Sonoline Antares Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005
Descendant · cites it directly · 801 of its ownK063803 Acuson Antares Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007 · Recalled
Descendant · 2 generations on · 800 of its ownK072786 Acuson S2000 Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2007
Descendant · 3 generations on · 588 of its ownK093563 IU22 Ultrasound System and TransducersPhilips Ultrasound, Inc. · 2010 · Recalled
Descendant · 3 generations on · 582 of its ownK083095 Sonixtouch Ultrasound SystemUltrasonix Medical Corporation · 2008
Descendant · 4 generations on · 569 of its ownK092271 GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3…GE Healthcare · 2009 · Recalled

Showing 5 of 921 descendants. See all descendants

Descendants cleared per year

2005high 79 (2025) · low 1 (2005)2026

Class I recalls in this family

K242670 Lumify Diagnostic Ultrasound System9 generations on · 2025
K242519 Lumify Diagnostic Ultrasound System9 generations on · 2025

Most influential descendants

Showing 5 of 921 · See all

K063803Acuson Antares Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007 · cites it directly801descendants
K072786Acuson S2000 Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2007 · 2 generations on800descendants
K093563IU22 Ultrasound System and TransducersPhilips Ultrasound, Inc. · 2010 · 3 generations on588descendants
K083095Sonixtouch Ultrasound SystemUltrasonix Medical Corporation · 2008 · 3 generations on582descendants
K092271GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4GE Healthcare · 2009 · 4 generations on569descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−5	K935595	Acuson Model 3001	Acuson Corp.	1995	—
−4	K973767	Harmonic Imaging with Contrast	Acuson Corp.	1997	—
−3	K022567	Sequoia Signature II Diagnostic Ultrasound System	Acuson Corp.	2002	—
−2	K032111	Acuson CV70 Cardiovascular System	Siemens Medical Solutions USA, Inc.	2003	1
−1	K040060	Sonoline G50 and G60 S Diagnostic Ultrasound Systems	Siemens Medical Solutions USA, Inc.	2004	—
0 (this device)	K050034	Sonoline Antares Diagnostic Ultrasound System	Siemens Medical Solutions USA, Inc.	2005	—
+1	K063803	Acuson Antares Diagnostic Ultrasound System	Siemens Medical Solutions USA, Inc., Ultrasound DI	2007	9
+2	K072786	Acuson S2000 Ultrasound System	Siemens Medical Solutions USA, Inc.	2007	—
+3	K093563	IU22 Ultrasound System and Transducers	Philips Ultrasound, Inc.	2010	2
+3	K083095	Sonixtouch Ultrasound System	Ultrasonix Medical Corporation	2008	—
+4	K092271	GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4	GE Healthcare	2009	1

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1992	1	0
1994	1	0
1995	3	0
1997	1	0
1999	3	0
2000	5	0
2002	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2005	1	0
2006	3	0
2007	5	0
2008	5	0
2009	11	0
2010	16	0
2011	25	0
2012	30	0
2013	41	0
2014	45	0
2015	53	0
2016	59	0
2017	75	0
2018	65	0
2019	49	0
2020	73	0
2021	53	0
2022	57	0
2023	57	0
2024	65	0
2025	79	2
2026	54	0

FIG. 1 — Lineage of K050034, 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.

2 devices in this family have a Class I recall. 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? (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
*	K001400	Elegra Millennium Enhanced Diagnostic Ultrasound System Summary page 1 …e, and is substantially equivalent to the following products which are already cleared for US distribution with the following 510O(k) clearances: * K001 400, 8/1 /00, cleared as the Elegra Millennium Advanced, marketed as the Antares * K040060, 01/28/04, clear…	Siemens Medical Solutions USA, Inc.	2000	1
*	K040060	Sonoline G50 and G60 S Diagnostic Ultrasound Systems Summary page 1 …n with the following 510O(k) clearances: * K001 400, 8/1 /00, cleared as the Elegra Millennium Advanced, marketed as the Antares * K040060, 01/28/04, cleared as SONOLINE G50/G60 S Diagnostic Ultrasound System 4. Device Description: The An…	Siemens Medical Solutions USA, Inc.	2004	—

Also cleared against K001400: 1 other device →

What descends from it? (921)

See all 921

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

Number	Device	Applicant	Decided	Descendants
K063803	Acuson Antares Diagnostic Ultrasound System	Siemens Medical Solutions USA, Inc., Ultrasound DI	2007	801
K061946	Acuson X300 Diagnostic Ultrasound System	Siemens Medical Solutions USA, Inc.	2006	428
K052895	Foursight Viewtool Image Viewer	Siemens Medical Solutions USA, Inc.	2005	102
K123185	DC-8/DC-8 Pro/DC-8, CV/DC-8, Exp/DC-8S Diagnostic Ultrasound System	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	2012	97
K060992	Syngo US Workplace	Siemens Medical Solutions	2006	97
K060879	Model EC9-4 Transducer	Siemens Medical Solutions USA, Inc.	2006	1

Has anything in its family been recalled? (2 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Mar 1, 2010	Not classified	Z-1853-2011	Software design	Image captured from the device may be erroneous.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

K242670Lumify Diagnostic Ultrasound SystemPhilips Ultrasound · 2025 · 9 generations on · ◆ in the 2025 descendants bar of FIG. 11 Class I recall
K242519Lumify Diagnostic Ultrasound SystemPhilips Ultrasound · 2025 · 9 generations on · ◆ in the 2025 descendants bar of FIG. 11 Class I recall

What does this lineage say?

The line of descent spans 10 years and passes through 2 companies; a new generation was cleared every 12 months on median.
4 of the 20 ancestors have a recall of any class.
Of its descendants, K063803 (Siemens Medical Solutions USA, Inc., Ultrasound DI, 2007) has gone furthest, with 801 descendants of its own.
1 other device also cites its predicate K001400.

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?

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

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K050034 · printed Nov 6, 2026

Cite this page

510(k) Report. “K050034: Sonoline Antares Diagnostic Ultrasound System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050034

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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