510(k) · Cleared
ClearedSonoline Elegra Diagnostic Ultrasound System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Medical Solutions USA, Inc. · IYO System, Imaging, Pulsed Echo, Ultrasonic
Cleared on Oct 28, 1998 as substantially equivalent to K973767 (Acuson Corp., 1997) and 1 other predicate after a 182-day review. Its family tree reaches back 2 generations to 1995. 1 later device descends from it.
- Decided
- Oct 28, 1998
- Review
- 182 days
- Class
- Class II
- Product code
- IYO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K935595 (1995). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 1 generation backK973767 Harmonic Imaging with ContrastAcuson Corp. · 1997
- This deviceK981528 Sonoline Elegra Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 1998
- Descendant · cites it directly · 0 of its ownK992046 Sonoline 7XX Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 1999
Most influential descendants
Showing 1 of 1 · See all- K992046Sonoline 7XX Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 1999 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K935595 | Acuson Model 3001 | Acuson Corp. | 1995 | — |
| −1 | K973767 | Harmonic Imaging with Contrast | Acuson Corp. | 1997 | — |
| 0 (this device) | K981528 | Sonoline Elegra Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 1998 | — |
| +1 | K992046 | Sonoline 7XX Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 1999 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
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 IYO? 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 IYO device
- #1 K243937 Accuro 3Sscore 20.5 · 18 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 | Decided |
|---|---|---|---|
| * | K973767 | Harmonic Imaging with ContrastSummary page 1…O Diagnostic Ultrasound Transducer FR # 892.1570 Product Code 90-ITX 3. Predicate Device: . Acuson Sequoia™ Ultrasound System and Harmonic Imaging with Contrast Option (K973767, 12/23/97) . SONOLINE Elegra (K945072, 11/21/95). 4, Device Description: The SONOLINE Elegra is a general purpose, mobile, softw… | 1997 |
| * | K945072 | Siemens Q4000Summary page 1…# 892.1570 Product Code 90-ITX 3. Predicate Device: . Acuson Sequoia™ Ultrasound System and Harmonic Imaging with Contrast Option (K973767, 12/23/97) . SONOLINE Elegra (K945072, 11/21/95). 4, Device Description: The SONOLINE Elegra is a general purpose, mobile, software-controlled, diagnostic ultrasound… | 1995 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K992046 | Sonoline 7XX Diagnostic Ultrasound System | 1999 | 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?
- The line of descent spans 3 years and passes through 2 companies; a new generation was cleared every 2.8 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K992046 (Siemens Medical Solutions USA, Inc., 1999) has gone furthest, with 0 descendants of its own.
- 7 other devices also cite its predicate K973767.
How does its category compare?
All IYO devicesIYO System, Imaging, Pulsed Echo, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IYO
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IYO
171in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IYO
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IYO
485in 2025
MAUDE reports naming product code IYO, 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 | 20 | 17 | 4 | 39 |
| 2008 | 14 | 36 | 5 | 20 |
| 2009 | 13 | 79 | 9 | 27 |
| 2010 | 15 | 113 | 8 | 20 |
| 2011 | 11 | 69 | 0 | 58 |
| 2012 | 15 | 68 | 2 | 78 |
| 2013 | 17 | 50 | 3 | 436 |
| 2014 | 14 | 63 | 2 | 304 |
| 2015 | 19 | 46 | 1 | 268 |
| 2016 | 10 | 36 | 0 | 254 |
| 2017 | 19 | 72 | 0 | 238 |
| 2018 | 14 | 56 | 1 | 368 |
| 2019 | 13 | 59 | 1 | 537 |
| 2020 | 11 | 57 | 0 | 498 |
| 2021 | 15 | 64 | 11 | 617 |
| 2022 | 5 | 190 | 1 | 511 |
| 2023 | 11 | 177 | 0 | 527 |
| 2024 | 10 | 220 | 0 | 640 |
| 2025 | 7 | 171 | 0 | 485 |
| 2026 | 10 | 139 | 1 | — |
What is it indicated for?
The SONOLINE Elegra ultrasound imaging system is intended for the following applications: General Radiology, Abdominal, intraoperative, Small Parts, Transcranial, OB/GYN, Pelvic, Neonatal/Adult Cephalic, Urology, Vascular, Musculoskeletal. Superficial Musculoskeletal, and Peripheral Vascular applications. The addition of contrast agent imaging will not add any new applications or intended uses.
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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K981528 · printed Nov 5, 2026
Cite this page
510(k) Report. “K981528: Sonoline Elegra Diagnostic Ultrasound System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K981528
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