510(k) · Cleared
Recalled · 2010Sonoline Antares Ultrasound System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Medical Solutions USA, Inc. · IYN System, Imaging, Pulsed Doppler, Ultrasonic
Cleared on Nov 20, 2002 as substantially equivalent to K001400 (Siemens Medical Solutions USA, Inc., 2000) and 1 other predicate after a 15-day review. Its family tree reaches back 1 generation to 2000. 2 of the 899 devices in its family, counting itself, have a Class I recall. 896 later devices descend from it. It has been recalled once.
- Decided
- Nov 20, 2002
- Review
- 15 days
- Class
- Class II
- Product code
- IYN
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 1 generation to K001400 (2000). 2 ancestors in all. 896 later devices descend from it, 5 citing it directly. 2 of the 899 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK001400 Elegra Millennium Enhanced Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2000 · Recalled
- This deviceK023720 Sonoline Antares Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2002
- Descendant · cites it directly · 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
- Descendant · cites it directly · 677 of its ownK034003 Hdi 5000 Diagnostic Ultrasound SystemPhilips Ultrasound, Inc. · 2004 · Recalled
- Descendant · 2 generations on · 676 of its ownK053069 Sonosite Micromaxx Diagnostic Ultrasound System (C3 Series)Sonosite,Inc. · 2005 · Recalled
Showing 5 of 896 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 896 · See all- K063138Modification to Acuson Antares Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006 · cites it directly802descendants
- 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
- K034003Hdi 5000 Diagnostic Ultrasound SystemPhilips Ultrasound, Inc. · 2004 · cites it directly677descendants
- K053069Sonosite Micromaxx Diagnostic Ultrasound System (C3 Series)Sonosite,Inc. · 2005 · 2 generations on676descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K001400 | Elegra Millennium Enhanced Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2000 | 1 |
| 0 (this device) | K023720 | Sonoline Antares Ultrasound System | Siemens Medical Solutions USA, Inc. | 2002 | — |
| +1 | 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 | — |
| +1 | K034003 | Hdi 5000 Diagnostic Ultrasound System | Philips Ultrasound, Inc. | 2004 | 4 |
| +2 | K053069 | Sonosite Micromaxx Diagnostic Ultrasound System (C3 Series) | Sonosite,Inc. | 2005 | 3 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
| 2007 | 4 | 0 |
| 2008 | 10 | 0 |
| 2009 | 8 | 0 |
| 2010 | 12 | 0 |
| 2011 | 21 | 0 |
| 2012 | 31 | 0 |
| 2013 | 39 | 0 |
| 2014 | 47 | 0 |
| 2015 | 53 | 0 |
| 2016 | 64 | 0 |
| 2017 | 73 | 0 |
| 2018 | 64 | 0 |
| 2019 | 50 | 0 |
| 2020 | 69 | 0 |
| 2021 | 52 | 0 |
| 2022 | 57 | 0 |
| 2023 | 54 | 0 |
| 2024 | 57 | 0 |
| 2025 | 75 | 2 |
| 2026 | 51 | 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.
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
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 |
|---|---|---|---|
| * | K001400 | Elegra Millennium Enhanced Diagnostic Ultrasound SystemSummary page 1…is substantially equivalent to the following products which are already cleared for US distribution with the following 51O(k) clearances: rn K001400, 8/1/00, cleared as the Elegra Millennium Advanced, marketed as the Antares rn K003525, 11/22/00… | 2000 |
| * | K003525 | Voluson 730 Diagnostic Ultrasound SystemSummary page 1…e following 51O(k) clearances: rn K001400, 8/1/00, cleared as the Elegra Millennium Advanced, marketed as the Antares rn K003525, 11/22/00, cleared as the Voluson 730 Diagnostic Ultrasound System, marketed as the GE Voluson 730 4D 4.… | 2000 |
What descends from it? (896)
See all 8965 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K063138 | Modification to Acuson Antares Ultrasound System | 2006 | 802 |
| K034003 | Hdi 5000 Diagnostic Ultrasound System | 2004 | 677 |
| K060992 | Syngo US Workplace | 2006 | 97 |
| K052355 | Automated Breast Ultrasound System, Model Abus | 2005 | 64 |
| K080930 | Modification to Automated Breast Ultrasound System, Model Abus | 2008 | 3 |
Has anything in its family been recalled? (2 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 1, 2010 | Not classified | Z-1853-2011 | Software design | Image captured from the device may be erroneous. |
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.
What does this lineage say?
How does its category compare?
All IYN devicesIYN System, Imaging, Pulsed Doppler, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IYN
57in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IYN
124in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IYN
10in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · IYN
610in 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?
The Antares ultrasound imaging system is intended for the following applications: General Radiology, Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Transesophageal, Pelvic, Neonatal/Adult Cephalic, Urology, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.
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 as stated in the FDA summary.
https://510kreport.com/device/K023720 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023720: Sonoline Antares 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/K023720
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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