510(k) · Cleared

Cleared

Siemens Q4000

K945072510(k) TraditionalCleared Nov 21, 1995400-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 21, 1995 after a 400-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 of the 1,035 devices in its family, counting itself, have a Class I recall. 1,034 later devices descend from it.

Decided: Nov 21, 1995
Review: 400 days
Class: Class II
Product code: IYN
Recalls: None
Predicates: 0

1,034 later devices descend from it, 6 citing it directly. 2 of the 1,035 devices in this family, counting this one, have a Class I recall.

This deviceK945072 Siemens Q4000Siemens Medical Solutions USA, Inc. · 1995
Descendant · cites it directly · 1,026 of its ownK020353 Omnia X/XS Ultrasound SystemSiemens Medical Systems, Inc. · 2002
Descendant · 2 generations on · 955 of its ownK032111 Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2003 · Recalled
Descendant · 2 generations on · 950 of its ownK040060 Sonoline G50 and G60 S Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc. · 2004
Descendant · 3 generations on · 932 of its ownK042770 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
Descendant · 2 generations on · 930 of its ownK040502 Sonoline Ebisu Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc. · 2004

Showing 5 of 1,034 descendants. See all descendants

Descendants cleared per year

1996high 83 (2025) · low 0 (2000)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 1,034 · See all

K020353Omnia X/XS Ultrasound SystemSiemens Medical Systems, Inc. · 2002 · cites it directly1,026descendants
K032111Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2003 · 2 generations on955descendants
K040060Sonoline G50 and G60 S Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc. · 2004 · 2 generations on950descendants
K042770Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2004 · 3 generations on932descendants
K040502Sonoline Ebisu Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc. · 2004 · 2 generations on930descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K945072	Siemens Q4000	Siemens Medical Solutions USA, Inc.	1995	—
+1	K020353	Omnia X/XS Ultrasound System	Siemens Medical Systems, Inc.	2002	—
+2	K032111	Acuson CV70 Cardiovascular System	Siemens Medical Solutions USA, Inc.	2003	1
+2	K040060	Sonoline G50 and G60 S Diagnostic Ultrasound Systems	Siemens Medical Solutions USA, Inc.	2004	—
+3	K042770	Modification to Acuson CV70 Cardiovascular System	Siemens Medical Solutions USA, Inc.	2004	1
+2	K040502	Sonoline Ebisu Diagnostic Ultrasound Systems	Siemens Medical Solutions USA, Inc.	2004	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1996	1	0
1997	1	0
1998	3	0
1999	1	0
2002	2	0
2003	3	0
2004	8	0
2005	10	0
2006	7	0
2007	14	0
2008	13	0
2009	18	0
2010	20	0
2011	29	0
2012	36	0
2013	46	0
2014	48	0
2015	60	0
2016	63	0
2017	78	0
2018	68	0
2019	51	0
2020	76	0
2021	55	0
2022	60	0
2023	59	0
2024	66	0
2025	83	2
2026	55	0

FIG. 1 — Lineage of K945072, 1995–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (1,034)

See all 1,034

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

Number	Device	Applicant	Decided	Descendants
K020353	Omnia X/XS Ultrasound System	Siemens Medical Systems, Inc.	2002	1,026
K981528	Sonoline Elegra Diagnostic Ultrasound System	Siemens Medical Solutions USA, Inc.	1998	1
K980557	Sonoline Elegra Diagnostic Ultrasound System with Superficial Musculoskeletal Imaging	Siemens Medical Solutions USA, Inc.	1998	1
K961833	Sonoline Elegra with Siescape Feature	Siemens Medical Solutions USA, Inc.	1996	1
K981626	Sonoline Elegra Diagnostic Ultrasound System	Siemens Medical Solutions USA, Inc.	1998	0
K962142	Sonoline Versa 555 Diagnostic Ultrasound System	Siemens Medical Solutions USA, Inc.	1997	0

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?

Of its descendants, K020353 (Siemens Medical Systems, Inc., 2002) has gone furthest, with 1,026 descendants of its own.

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)	—

https://510kreport.com/device/K945072 · printed Nov 4, 2026

Cite this page

510(k) Report. “K945072: Siemens Q4000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K945072

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026