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 May 27, 1998 as substantially equivalent to K945072 (Siemens Medical Solutions USA, Inc., 1995) and 2 other predicates after a 20-day review. Its family tree reaches back 2 generations to 1991.
- Decided
- May 27, 1998
- Review
- 20 days
- Class
- Class II
- Product code
- IYO
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K904019 (1991). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK904019 Quantum 2000 Angiodynograph Ultrasound SystemQuantum Medical Systems, Inc. · 1991
- 1 generation backK950157 Siemens Q64XXXSiemens Medical Solutions USA, Inc. · 1996
- This deviceK981626 Sonoline Elegra Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K904019 | Quantum 2000 Angiodynograph Ultrasound System | Quantum Medical Systems, Inc. | 1991 | — |
| −1 | K950157 | Siemens Q64XXX | Siemens Medical Solutions USA, Inc. | 1996 | — |
| 0 (this device) | K981626 | Sonoline Elegra Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 1998 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1996 | 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? (3)
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…Diagnostic Ultrasound System with Accessories Classification Name: Ultrasonic Pulsed Doppler Imaging System (Product Code 90 IYN, 21 CFR 892.1550) 3. Predicate Device: K945072, 11/21/95, cleared as the Q4000, marketed as the SONOLINE Elegra Advanced K950517, 4/5/96, cleared as Q64XX, marketed as the SONO… | 1995 |
| * | K950157 | Siemens Q64XXX Our OCR of the scanned summary read K950517, FDA’s number for Harmony Line PF (Ivoclar North America, Inc.). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “Q64XX, marketed as the SONOLINE Elegra”. | 1996 |
| * | K961833 | Sonoline Elegra with Siescape FeatureSummary page 1…3. Predicate Device: K945072, 11/21/95, cleared as the Q4000, marketed as the SONOLINE Elegra Advanced K950517, 4/5/96, cleared as Q64XX, marketed as the SONOLINE Elegra K961833, 10/29/96, SieScape panoramic display for SONOLINE Elegra Advanced 4, Device Description: The SONOLINE Elegra is a general purpo… | 1996 |
What descends from it?
No later submission names this one as a predicate yet.
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 7 years and passes through 2 companies; a new generation was cleared every 5.0 years on median.
- None of the 4 ancestors has a recall.
- 5 other devices also cite its predicate K945072.
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 3-D imaging will not add new indications for use to the Elegra. It will allow the user to display regions of interest in 3-dimensional…
Read the full statement (98 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, Musculoskeletal. Superficial Musculoskeletal, and Peripheral Vascular applications. The addition of 3-D imaging will not add new indications for use to the Elegra. It will allow the user to display regions of interest in 3-dimensional format, either by showing views in three orthagonal planes or allowing surface rendering of objects.
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/K981626 · printed Nov 4, 2026
Cite this page
510(k) Report. “K981626: Sonoline Elegra Diagnostic Ultrasound System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K981626
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