510(k) · Cleared

Recalled · 2008

Sonoline G60 S Ultrasound System

K052894510(k) SpecialCleared Nov 23, 200540-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 Nov 23, 2005 as substantially equivalent to K040060 (Siemens Medical Solutions USA, Inc., 2004) and 3 other predicates after a 40-day review. Its family tree reaches back 7 generations to 1995. 2 of the 961 devices in its family, counting itself, have a Class I recall. 926 later devices descend from it. It has been recalled once.

Decided: Nov 23, 2005
Review: 40 days
Class: Class II
Product code: IYN
Recalls: 1
Predicates: 4

Its longest line of descent runs back 7 generations to K935595 (1995). 34 ancestors in all, the oldest K921148 (1992). 926 later devices descend from it, 3 citing it directly. 2 of the 961 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 7 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
6 generations backK973767 Harmonic Imaging with ContrastAcuson Corp. · 1997
5 generations backK022567 Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002
4 generations backK032114 Sequoia 8.0 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2003
3 generations backK041319 Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004
2 generations backK042770 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
1 generation backK050240 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
This deviceK052894 Sonoline G60 S Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005
Descendant · cites it directly · 802 of its ownK063138 Modification to Acuson Antares Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006
Descendant · 2 generations on · 801 of its ownK063803 Acuson Antares Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007 · Recalled
Descendant · 3 generations on · 800 of its ownK072786 Acuson S2000 Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2007
Descendant · 4 generations on · 588 of its ownK093563 IU22 Ultrasound System and TransducersPhilips Ultrasound, Inc. · 2010 · Recalled
Descendant · 4 generations on · 582 of its ownK083095 Sonixtouch Ultrasound SystemUltrasonix Medical Corporation · 2008

Showing 5 of 926 descendants. See all descendants

Descendants cleared per year

2006high 79 (2025) · low 3 (2006)2026

Class I recalls in this family

K242670 Lumify Diagnostic Ultrasound System10 generations on · 2025
K242519 Lumify Diagnostic Ultrasound System10 generations on · 2025

Most influential descendants

Showing 5 of 926 · See all

K063138Modification to Acuson Antares Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006 · cites it directly802descendants
K063803Acuson Antares Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007 · 2 generations on801descendants
K072786Acuson S2000 Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2007 · 3 generations on800descendants
K093563IU22 Ultrasound System and TransducersPhilips Ultrasound, Inc. · 2010 · 4 generations on588descendants
K083095Sonixtouch Ultrasound SystemUltrasonix Medical Corporation · 2008 · 4 generations on582descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−7	K935595	Acuson Model 3001	Acuson Corp.	1995	—
−6	K973767	Harmonic Imaging with Contrast	Acuson Corp.	1997	—
−5	K022567	Sequoia Signature II Diagnostic Ultrasound System	Acuson Corp.	2002	—
−4	K032114	Sequoia 8.0 Diagnostic Ultrasound System	Siemens Medical Solutions USA, Inc.	2003	—
−3	K041319	Sequoia Diagnostic Ultrasound System	Siemens Medical Solutions USA, Inc.	2004	—
−2	K042770	Modification to Acuson CV70 Cardiovascular System	Siemens Medical Solutions USA, Inc.	2004	1
−1	K050240	Modification to Acuson CV70 Cardiovascular System	Siemens Medical Solutions USA, Inc.	2005	1
0 (this device)	K052894	Sonoline G60 S Ultrasound System	Siemens Medical Solutions USA, Inc.	2005	—
+1	K063138	Modification to Acuson Antares Ultrasound System	Siemens Medical Solutions USA, Inc.	2006	—
+2	K063803	Acuson Antares Diagnostic Ultrasound System	Siemens Medical Solutions USA, Inc., Ultrasound DI	2007	9
+3	K072786	Acuson S2000 Ultrasound System	Siemens Medical Solutions USA, Inc.	2007	—
+4	K093563	IU22 Ultrasound System and Transducers	Philips Ultrasound, Inc.	2010	2
+4	K083095	Sonixtouch Ultrasound System	Ultrasonix Medical Corporation	2008	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1992	1	0
1994	2	0
1995	4	0
1997	2	0
1999	4	0
2000	4	0
2001	1	0
2002	1	0
2003	2	0
2004	6	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2006	3	0
2007	6	0
2008	8	0
2009	13	0
2010	15	0
2011	26	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 K052894, 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? (4)

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
*	K040060	Sonoline G50 and G60 S Diagnostic Ultrasound Systems Summary page 1 …892.1560 90-IYO Diagnostic Ultrasound Transducer 892.1570 90-ITX Predicate Device(s): * # K040060 (January 28, 2004), cleared as SONOLINE G50TM and SONOLINE G60 STM Diagnostic Ultrasound Systems. * # K042833 (October 27, 2004…	Siemens Medical Solutions USA, Inc.	2004	—
*	K042833	Sonoline G20 Diagnostic Ultrasound Systems Summary page 1 …892.1570 90-ITX Predicate Device(s): * # K040060 (January 28, 2004), cleared as SONOLINE G50TM and SONOLINE G60 STM Diagnostic Ultrasound Systems. * # K042833 (October 27, 2004), cleared as SONOLINE G20 TM Diagnostic Ultrasound System. * # K043016 (November 16, 2004), cleared as SONOLI…	Siemens Medical Solutions USA, Inc.	2004	—
*	K043016	Sonoline Orchid Diagnostic Ultrasound System Summary page 1 …ed as SONOLINE G50TM and SONOLINE G60 STM Diagnostic Ultrasound Systems. * # K042833 (October 27, 2004), cleared as SONOLINE G20 TM Diagnostic Ultrasound System. * # K043016 (November 16, 2004), cleared as SONOLINE OrchidTM Diagnostic Ultrasound System. · # K050240 (March 9, 2005), cleared as ACUSO C…	Siemens Medical Solutions USA, Inc.	2004	—
*	K050240	Modification to Acuson CV70 Cardiovascular System Summary page 1 …r 27, 2004), cleared as SONOLINE G20 TM Diagnostic Ultrasound System. * # K043016 (November 16, 2004), cleared as SONOLINE OrchidTM Diagnostic Ultrasound System. · # K050240 (March 9, 2005), cleared as ACUSO CV70TM Cardiovascular System. Section II 510(k) Summary of Safet…	Siemens Medical Solutions USA, Inc.	2005	1

Also cleared against K040060: 5 other devices →

What descends from it? (926)

See all 926

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

Number	Device	Applicant	Decided	Descendants
K063138	Modification to Acuson Antares Ultrasound System	Siemens Medical Solutions USA, Inc.	2006	802
K061946	Acuson X300 Diagnostic Ultrasound System	Siemens Medical Solutions USA, Inc.	2006	428
K063500	DC-6 Diagnostic Ultrasound System	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	2006	189

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Aug 5, 2008	Not classified	Z-2468-2008	Software design	As a result of bugs and calculation errors, the system may display incorrect or fail to display mechanical Index and thermal index values.

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 · 10 generations on · ◆ in the 2025 descendants bar of FIG. 11 Class I recall
K242519Lumify Diagnostic Ultrasound SystemPhilips Ultrasound · 2025 · 10 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 11 months on median.
7 of the 34 ancestors have a recall of any class.
Of its descendants, K063138 (Siemens Medical Solutions USA, Inc., 2006) has gone furthest, with 802 descendants of its own.
5 other devices also cite its predicate K040060.

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/K052894 · printed Nov 6, 2026

Cite this page

510(k) Report. “K052894: Sonoline G60 S 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/K052894

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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