510(k) · Cleared
ClearedSonoline Elegra with Siescape Feature
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 29, 1996 as substantially equivalent to K945072 (Siemens Medical Solutions USA, Inc., 1995) after a 169-day review. Its family tree reaches back 1 generation to 1995. 1 later device descends from it.
- Decided
- Oct 29, 1996
- Review
- 169 days
- Class
- Class II
- Product code
- IYO
- 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.
- Root · 1 generation backK945072 Siemens Q4000Siemens Medical Solutions USA, Inc. · 1995
- This deviceK961833 Sonoline Elegra with Siescape FeatureSiemens Medical Solutions USA, Inc. · 1996
- Descendant · cites it directly · 0 of its ownK981626 Sonoline Elegra Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 1998
Most influential descendants
Showing 1 of 1 · See all- K981626Sonoline Elegra Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 1998 · 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) | 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 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 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? (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 | Decided |
|---|---|---|---|
| * | K945072 | Siemens Q4000Summary page 1…Uitrasonic Pulsed Doppler Imaging System (Product Code 90 IYN, 21 CFR 892.1550) 3. Predicate Device: Siemens SONOLINE Elegra Platform 256 Diagnostic Ultrasound System (K945072), 11/21/95 4. Device Description: The SONOLINE Elegra is a general purpose, mobile, software-controlied, diagnostic ultrasound s… | 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 |
|---|---|---|---|
| K981626 | Sonoline Elegra Diagnostic Ultrasound System | 1998 | 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?
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, and Peripheral Vascular applications. The addition of SieScape with Measurements will not change or add to the intended uses above, which are identical to those included in the original submission for the Elegra. The system also…
Read the full statement (105 words)
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, and Peripheral Vascular applications. The addition of SieScape with Measurements will not change or add to the intended uses above, which are identical to those included in the original submission for the Elegra.
The system also provides for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes. The addition of SieScape with Measurements will allow for measurements across a wider field of view than with standard B-mode imaging ultrasound systems.
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/K961833 · printed Nov 4, 2026
Cite this page
510(k) Report. “K961833: Sonoline Elegra with Siescape Feature.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K961833
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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