510(k) · Cleared

Recalled · 2003

Elegra Millennium Enhanced Diagnostic Ultrasound System

K001400510(k) TraditionalCleared Aug 1, 200090-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 Aug 1, 2000 after a 90-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 of the 983 devices in its family, counting itself, have a Class I recall. 982 later devices descend from it. It has been recalled once.

Decided: Aug 1, 2000
Review: 90 days
Class: Class II
Product code: IYN
Recalls: 1
Predicates: 0

982 later devices descend from it, 2 citing it directly. 2 of the 983 devices in this family, counting this one, have a Class I recall.

This deviceK001400 Elegra Millennium Enhanced Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2000
Descendant · cites it directly · 921 of its ownK050034 Sonoline Antares Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
Descendant · cites it directly · 896 of its ownK023720 Sonoline Antares Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2002 · Recalled
Descendant · 2 generations on · 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

Showing 5 of 982 descendants. See all descendants

Descendants cleared per year

2002high 83 (2025) · low 0 (2003)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 982 · See all

K050034Sonoline Antares Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005 · cites it directly921descendants
K023720Sonoline Antares Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2002 · cites it directly896descendants
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 · 2 generations on801descendants
K072786Acuson S2000 Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2007 · 3 generations on800descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K001400	Elegra Millennium Enhanced Diagnostic Ultrasound System	Siemens Medical Solutions USA, Inc.	2000	—
+1	K050034	Sonoline Antares Diagnostic Ultrasound System	Siemens Medical Solutions USA, Inc.	2005	1
+1	K023720	Sonoline Antares Ultrasound System	Siemens Medical Solutions USA, Inc.	2002	1
+2	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	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	1	0
2004	1	0
2005	4	0
2006	4	0
2007	7	0
2008	11	0
2009	13	0
2010	19	0
2011	27	0
2012	34	0
2013	46	0
2014	47	0
2015	57	0
2016	64	0
2017	77	0
2018	67	0
2019	51	0
2020	74	0
2021	56	0
2022	59	0
2023	59	0
2024	66	0
2025	83	2
2026	55	0

FIG. 1 — Lineage of K001400, 2000–2026Source: 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? (982)

See all 982

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

Number	Device	Applicant	Decided	Descendants
K050034	Sonoline Antares Diagnostic Ultrasound System	Siemens Medical Solutions USA, Inc.	2005	921
K023720	Sonoline Antares Ultrasound System	Siemens Medical Solutions USA, Inc.	2002	896

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Sep 5, 2003	Not classified	Z-0041-04	Other	Product labeling failed to include complete information about ALARA (As Low As Reasonably Achievable) safety instructions.

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?

Of its descendants, K050034 (Siemens Medical Solutions USA, Inc., 2005) has gone furthest, with 921 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/K001400 · printed Nov 6, 2026

Cite this page

510(k) Report. “K001400: Elegra Millennium Enhanced 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/K001400

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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