510(k) · Cleared

Cleared

Acuson Sequoia Diagnostic Ultrasound System

K051139510(k) TraditionalCleared May 13, 20059-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 May 13, 2005 as substantially equivalent to K041319 (Siemens Medical Solutions USA, Inc., 2004) and 2 other predicates after a 9-day review. Its family tree reaches back 5 generations to 1995. 2 of the 1,000 devices in its family, counting itself, have a Class I recall. 979 later devices descend from it.

Decided: May 13, 2005
Review: 9 days
Class: Class II
Product code: IYN
Recalls: None
Predicates: 3

Its longest line of descent runs back 5 generations to K935595 (1995). 20 ancestors in all, the oldest K921148 (1992). 979 later devices descend from it, 5 citing it directly. 2 of the 1,000 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 backK032114 Sequoia 8.0 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2003
1 generation backK041319 Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004
This deviceK051139 Acuson Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005
Descendant · cites it directly · 972 of its ownK052410 Acuson Sequoia Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005
Descendant · 2 generations on · 838 of its ownK063085 Modification to Acuson Sequoia Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006 · Recalled
Descendant · cites it directly · 806 of its ownK052021 V5MS Transducer and MPT7-4 Multiplane Transesophageal TransducerSiemens Medical Solutions USA, Inc. · 2005 · Recalled
Descendant · 2 generations on · 802 of its ownK063138 Modification to Acuson Antares Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006
Descendant · 3 generations on · 801 of its ownK063803 Acuson Antares Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007 · Recalled

Showing 5 of 979 descendants. See all descendants

Descendants cleared per year

2005high 80 (2025) · low 2 (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 979 · See all

K052410Acuson Sequoia Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005 · cites it directly972descendants
K063085Modification to Acuson Sequoia Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006 · 2 generations on838descendants
K052021V5MS Transducer and MPT7-4 Multiplane Transesophageal TransducerSiemens Medical Solutions USA, Inc. · 2005 · cites it directly806descendants
K063138Modification to Acuson Antares Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006 · 2 generations on802descendants
K063803Acuson Antares Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007 · 3 generations on801descendants

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	K032114	Sequoia 8.0 Diagnostic Ultrasound System	Siemens Medical Solutions USA, Inc.	2003	—
−1	K041319	Sequoia Diagnostic Ultrasound System	Siemens Medical Solutions USA, Inc.	2004	—
0 (this device)	K051139	Acuson Sequoia Diagnostic Ultrasound System	Siemens Medical Solutions USA, Inc.	2005	—
+1	K052410	Acuson Sequoia Ultrasound System	Siemens Medical Solutions USA, Inc.	2005	—
+2	K063085	Modification to Acuson Sequoia Ultrasound System	Siemens Medical Solutions USA, Inc.	2006	3
+1	K052021	V5MS Transducer and MPT7-4 Multiplane Transesophageal Transducer	Siemens Medical Solutions USA, Inc.	2005	1
+2	K063138	Modification to Acuson Antares Ultrasound System	Siemens Medical Solutions USA, Inc.	2006	—
+3	K063803	Acuson Antares Diagnostic Ultrasound System	Siemens Medical Solutions USA, Inc., Ultrasound DI	2007	9

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1992	1	0
1994	1	0
1995	1	0
1997	1	0
1999	3	0
2000	3	0
2001	1	0
2002	1	0
2003	2	0
2004	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2005	2	0
2006	4	0
2007	9	0
2008	13	0
2009	20	0
2010	17	0
2011	29	0
2012	36	0
2013	42	0
2014	50	0
2015	59	0
2016	59	0
2017	77	0
2018	68	0
2019	49	0
2020	75	0
2021	54	0
2022	59	0
2023	57	0
2024	65	0
2025	80	2
2026	55	0

FIG. 1 — Lineage of K051139, 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? (3)

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
*	K041319	Sequoia Diagnostic Ultrasound System Summary page 1 …892.1570 90-ITX Diagnostic Intravascular Catheter 870.1200 74-DQO 3. Predicate Devices: # K0413 19 (June 7, 2004), cleared as Sequoia Diagnostic Ultrasound System. #K022303 (July 30, 2002), cleared as P…	Siemens Medical Solutions USA, Inc.	2004	—
*	K022303	Philips M2424 Diagnostic Ultrasound System &Philips 21315 Diagnostic Ultrasound Transducer Summary page 1 …870.1200 74-DQO 3. Predicate Devices: # K0413 19 (June 7, 2004), cleared as Sequoia Diagnostic Ultrasound System. #K022303 (July 30, 2002), cleared as Philips M2424 Diagnostic Ultrasound System with 21315 ultrasound transducer.…	Philips Ultrasound, Inc.	2002	—
*	K041552	GE Vivid 7 BT04 Summary page 2 …ACUSONr Sequoia Diagnostic Ultrasound System Ultrasound Division 510(k) Submission · #K041552 (July 2, 2004), cleared as GE Vivid 7Diagnostic Ultrasound System with EchoPAC BT04. 4. Device Description: The…	General Electric Co.	2004	—

Also cleared against K041319: 2 other devices →

What descends from it? (979)

See all 979

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

Number	Device	Applicant	Decided	Descendants
K052410	Acuson Sequoia Ultrasound System	Siemens Medical Solutions USA, Inc.	2005	972
K052021	V5MS Transducer and MPT7-4 Multiplane Transesophageal Transducer	Siemens Medical Solutions USA, Inc.	2005	806
K072365	Sequoia Plus Diagnostic Ultrasound System	Siemens Medical Solutions USA, Inc., Ultrasound DI	2007	233
K102017	SC2000 Diagnostic Ultrasound System	Siemens Medical Solutions USA, Inc.	2010	104
K060992	Syngo US Workplace	Siemens Medical Solutions	2006	97

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 10 years and passes through 2 companies; a new generation was cleared every 11 months on median.
3 of the 20 ancestors have a recall of any class.
Of its descendants, K052410 (Siemens Medical Solutions USA, Inc., 2005) has gone furthest, with 972 descendants of its own.
2 other devices also cite its predicate K041319.

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 Sequoia platform is intended for use in the following applications:

General Imaging and Cardiology for Fetal, Abdominal, Intraoperative (abdominal and neurological), Pediatrics, Small Organs (breast, testes, thyroid, penis and prostate), Neonatal/Adult Cephalic, Cardiac (adult, pediatric, and neonatal), Trans-esophageal, Transrectal, Transvaginal, Peripheral Vessel, and Musculo-sceletal (superficial and conventional) applications, and intended uses as defined in the FDA guidance document.

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/K051139 · printed Nov 6, 2026

Cite this page

510(k) Report. “K051139: Acuson Sequoia 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/K051139

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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