510(k) · Cleared

Cleared

Siemens Acuson X500 Ultrasound System

K061980510(k) SpecialCleared Aug 17, 200635-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 Aug 17, 2006 after a 35-day review. The FDA summary names its predicate without a number. 425 later devices descend from it.

Decided: Aug 17, 2006
Review: 35 days
Class: Class II
Product code: IYN
Recalls: None
Predicates: 0

425 later devices descend from it, 3 citing it directly.

This deviceK061980 Siemens Acuson X500 Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006
Descendant · cites it directly · 330 of its ownK083149 Arterial Health Package (Ahp) SoftwareSiemens Medical Solutions USA, Inc. · 2009
Descendant · 2 generations on · 277 of its ownK090276 Acuson X300 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2009
Descendant · cites it directly · 189 of its ownK072090 Siemens Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007
Descendant · 3 generations on · 176 of its ownK092691 DC-7 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2009
Descendant · 4 generations on · 138 of its ownK100830 M7/M7T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2010

Showing 5 of 425 descendants. See all descendants

Descendants cleared per year

2007high 50 (2025) · low 0 (2008)2026

Most influential descendants

Showing 5 of 425 · See all

K083149Arterial Health Package (Ahp) SoftwareSiemens Medical Solutions USA, Inc. · 2009 · cites it directly330descendants
K090276Acuson X300 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2009 · 2 generations on277descendants
K072090Siemens Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007 · cites it directly189descendants
K092691DC-7 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2009 · 3 generations on176descendants
K100830M7/M7T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2010 · 4 generations on138descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K061980	Siemens Acuson X500 Ultrasound System	Siemens Medical Solutions USA, Inc.	2006	—
+1	K083149	Arterial Health Package (Ahp) Software	Siemens Medical Solutions USA, Inc.	2009	—
+2	K090276	Acuson X300 Diagnostic Ultrasound System	Siemens Medical Solutions USA, Inc.	2009	—
+1	K072090	Siemens Diagnostic Ultrasound Systems	Siemens Medical Solutions USA, Inc., Ultrasound DI	2007	—
+3	K092691	DC-7 Diagnostic Ultrasound System	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	2009	—
+4	K100830	M7/M7T Diagnostic Ultrasound System	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	2010	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2007	1	0
2009	6	0
2010	6	0
2011	11	0
2012	11	0
2013	18	0
2014	9	0
2015	22	0
2016	16	0
2017	39	0
2018	24	0
2019	22	0
2020	42	0
2021	26	0
2022	30	0
2023	26	0
2024	39	0
2025	50	0
2026	27	0

FIG. 1 — Lineage of K061980, 2006–2026Source: 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.

Planning a device in IYN? 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? (1)

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
*	—	Siemens Sonoline G60S ultrasound system Named without a submission number			—
†	K052894	Sonoline G60 S Ultrasound System	Siemens Medical Solutions USA, Inc.	2005	1
†	K040060	Sonoline G50 and G60 S Diagnostic Ultrasound Systems	Siemens Medical Solutions USA, Inc.	2004	—
†	K033196	Sonoline Antares with Clarify VE	Siemens Medical Solutions USA, Inc.	2003	1
†	K050240	Modification to Acuson CV70 Cardiovascular System	Siemens Medical Solutions USA, Inc.	2005	1
†	K043016	Sonoline Orchid Diagnostic Ultrasound System	Siemens Medical Solutions USA, Inc.	2004	—

What descends from it? (425)

See all 425

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

Number	Device	Applicant	Decided	Descendants
K083149	Arterial Health Package (Ahp) Software	Siemens Medical Solutions USA, Inc.	2009	330
K072090	Siemens Diagnostic Ultrasound Systems	Siemens Medical Solutions USA, Inc., Ultrasound DI	2007	189
K093531	Acuson Model X300 Diagnostic Ultrasound System	Siemens Medi Cal Solutions, Inc.	2009	99

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Of its descendants, K083149 (Siemens Medical Solutions USA, Inc., 2009) has gone furthest, with 330 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)	—

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/K061980 · printed Nov 6, 2026

Cite this page

510(k) Report. “K061980: Siemens Acuson X500 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/K061980

Report an extraction error

Are you the manufacturer?

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