510(k) · Cleared

Cleared

Modification to Acuson Antares Ultrasound System

K063138510(k) SpecialCleared Nov 22, 200637-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

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

Cleared on Nov 22, 2006 as substantially equivalent to K052894 (Siemens Medical Solutions USA, Inc., 2005) and 4 other predicates after a 37-day review. Its family tree reaches back 8 generations to 1995. 2 of the 855 devices in its family, counting itself, have a Class I recall. 802 later devices descend from it.

Decided: Nov 22, 2006
Review: 37 days
Class: Class II
Product code: IYN
Recalls: None
Predicates: 5

Its longest line of descent runs back 8 generations to K935595 (1995). 52 ancestors in all, the oldest K891689 (1989). 802 later devices descend from it, 1 citing it directly. 2 of the 855 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 8 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
7 generations backK973767 Harmonic Imaging with ContrastAcuson Corp. · 1997
6 generations backK022567 Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002
5 generations backK032114 Sequoia 8.0 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2003
4 generations backK041319 Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004
3 generations backK042770 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
2 generations backK050240 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
1 generation backK052894 Sonoline G60 S Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
This deviceK063138 Modification to Acuson Antares Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006
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 802 descendants. See all descendants

Descendants cleared per year

2007high 69 (2017) · low 2 (2007)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 802 · 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
−8	K935595	Acuson Model 3001	Acuson Corp.	1995	—
−7	K973767	Harmonic Imaging with Contrast	Acuson Corp.	1997	—
−6	K022567	Sequoia Signature II Diagnostic Ultrasound System	Acuson Corp.	2002	—
−5	K032114	Sequoia 8.0 Diagnostic Ultrasound System	Siemens Medical Solutions USA, Inc.	2003	—
−4	K041319	Sequoia Diagnostic Ultrasound System	Siemens Medical Solutions USA, Inc.	2004	—
−3	K042770	Modification to Acuson CV70 Cardiovascular System	Siemens Medical Solutions USA, Inc.	2004	1
−2	K050240	Modification to Acuson CV70 Cardiovascular System	Siemens Medical Solutions USA, Inc.	2005	1
−1	K052894	Sonoline G60 S Ultrasound System	Siemens Medical Solutions USA, Inc.	2005	1
0 (this device)	K063138	Modification to Acuson Antares Ultrasound System	Siemens Medical Solutions USA, Inc.	2006	—
+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
1989	1	0
1992	1	0
1994	4	0
1995	4	0
1997	3	0
1998	1	0
1999	5	0
2000	5	0
2001	3	0
2002	4	0
2003	3	0
2004	8	0
2005	2	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2007	2	0
2008	3	0
2009	5	0
2010	9	0
2011	18	0
2012	27	0
2013	32	0
2014	45	0
2015	49	0
2016	58	0
2017	69	0
2018	61	0
2019	46	0
2020	63	0
2021	48	0
2022	52	0
2023	50	0
2024	54	0
2025	65	2
2026	46	0

FIG. 1 — Lineage of K063138, 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

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What was it cleared against? (5)

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
*	K052894	Sonoline G60 S Ultrasound System Summary page 1 …Product Code 90-1TX A. Legally MarketedPredicate Devices The Siemens Antares Ultrasound system is substantially equivalent to the following K052894, K033196, K023729, 1/1/2005, Antares Diagnostic Ultrasound System , K052021, 8/17/2005, Siemens V5M Transesophageal T…	Siemens Medical Solutions USA, Inc.	2005	1
*	K033196	Sonoline Antares with Clarify VE Summary page 1 …Product Code 90-1TX A. Legally MarketedPredicate Devices The Siemens Antares Ultrasound system is substantially equivalent to the following K052894, K033196, K023729, 1/1/2005, Antares Diagnostic Ultrasound System , K052021, 8/17/2005, Siemens V5M Transesophageal Transducer…	Siemens Medical Solutions USA, Inc.	2003	1
*	K023720	Sonoline Antares Ultrasound System Our reading of the summary gave K023729, FDA’s number for Siascope II (Astron Clinica Limited). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Antares Diagnostic Ultrasound System”.	Siemens Medical Solutions USA, Inc.	2002	1
*	K052021	V5MS Transducer and MPT7-4 Multiplane Transesophageal Transducer Summary page 1 …ares Ultrasound system is substantially equivalent to the following K052894, K033196, K023729, 1/1/2005, Antares Diagnostic Ultrasound System , K052021, 8/17/2005, Siemens V5M Transesophageal Transducer KO 11252, 5/30/2001, GE Hitachi EUB 8500 with Sonoelastography…	Siemens Medical Solutions USA, Inc.	2005	1
*	K011252	Eub-6000 Diagnostic Ultrasound Scanner SP-711 Sonoprobe System Summary page 3 …* K052894, K033196, K023729, 1/1/2005, Antares Diagnostic Ultrasound System * K052021, 8/17/2005, Siemens V5M Transesophageal Transducer K011252, 5/30/2001, GE Hitachi EUB 8500 with Sonoelastography K B.Device Description: The Siemens Acuson ANT…	Hitachi Medical Corp.	2001	—

Also cleared against K052894: 2 other devices →

What descends from it? (802)

See all 802

1 later device cites 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

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

No FDA recall names this device.

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 11 years and passes through 2 companies; a new generation was cleared every 11 months on median.
12 of the 52 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.
2 other devices also cite its predicate K052894.

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?

The Acuson Antares ultrasound imaging system is intended for the following applications: Abdominal, Intraoperative, Small Parts, Transcranial, OB/GYN, Cardiac, Intracardiac, Transesophageal, Pelvic, Neonatal/Adult Cephalic, Vascular, Intravascular, Musculoskeletal, Superficial Musculoskeletal, Great Vessel, and Peripheral Vascular applications.

The system also provides for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K063138 · printed Nov 4, 2026

Cite this page

510(k) Report. “K063138: Modification to Acuson Antares Ultrasound System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063138

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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