510(k) · Cleared

Cleared

Sonoline Elegra Diagnostic Ultrasound System with Superficial Musculoskeletal Imaging

K980557510(k) TraditionalCleared Apr 24, 199870-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 Apr 24, 1998 as substantially equivalent to K945072 (Siemens Medical Solutions USA, Inc., 1995) after a 70-day review. Its family tree reaches back 1 generation to 1995. 1 later device descends from it.

Decided: Apr 24, 1998
Review: 70 days
Class: Class II
Product code: IYN
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K945072 (1995). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK945072 Siemens Q4000Siemens Medical Solutions USA, Inc. · 1995
This deviceK980557 Sonoline Elegra Diagnostic Ultrasound System with Superficial…Siemens Medical Solutions USA, Inc. · 1998
Descendant · cites it directly · 0 of its ownK023457 Ultrasound Scanner, Type 1101B-K Medical A/S · 2002

Most influential descendants

Showing 1 of 1 · See all

K023457Ultrasound Scanner, Type 1101B-K Medical A/S · 2002 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K945072	Siemens Q4000	Siemens Medical Solutions USA, Inc.	1995	—
0 (this device)	K980557	Sonoline Elegra Diagnostic Ultrasound System with Superficial Musculoskeletal…	Siemens Medical Solutions USA, Inc.	1998	—
+1	K023457	Ultrasound Scanner, Type 1101	B-K Medical A/S	2002	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	1	0

FIG. 1 — Lineage of K980557, 1995–2002Source: 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
*	K945072	Siemens Q4000 Summary page 1 …ies Classification Name: Ultrasonic Pulsed Doppler Imaging System (Product Code 90 YN, 21 CFR 892.1550) 3. Predicate Device: Siemens SONOLINE Elegra Ultrasound System (K945072), 11/21/85 4. Device Description: The SONOLINE Elegra is a general purpose, mobile, software-controlled, diagnostic ultrasound s…	Siemens Medical Solutions USA, Inc.	1995	—

Also cleared against K945072: 5 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K023457	Ultrasound Scanner, Type 1101	B-K Medical A/S	2002	0

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?

Its one ancestor has no recall.
Of its descendants, K023457 (B-K Medical A/S, 2002) has gone furthest, with 0 descendants of its own.
5 other devices also cite its predicate K945072.

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?

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K980557 · printed Nov 5, 2026

Cite this page

510(k) Report. “K980557: Sonoline Elegra Diagnostic Ultrasound System with Superficial Musculoskeletal Imaging.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K980557

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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