510(k) · Cleared
ClearedOmnia X/XS Ultrasound System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Medical Systems, Inc. · IYN System, Imaging, Pulsed Doppler, Ultrasonic
Cleared on Feb 13, 2002 as substantially equivalent to K945773 (Siemens Medical Solutions USA, Inc., 1995) and 1 other predicate after a 9-day review. Its family tree reaches back 1 generation to 1995. 2 of the 1,029 devices in its family, counting itself, have a Class I recall. 1,026 later devices descend from it.
- Decided
- Feb 13, 2002
- Review
- 9 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K945773 (1995). 2 ancestors in all. 1,026 later devices descend from it, 9 citing it directly. 2 of the 1,029 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK945773 Siemens Sonoline VersaSiemens Medical Solutions USA, Inc. · 1995
- This deviceK020353 Omnia X/XS Ultrasound SystemSiemens Medical Systems, Inc. · 2002
- Descendant · cites it directly · 955 of its ownK032111 Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2003 · Recalled
- Descendant · cites it directly · 950 of its ownK040060 Sonoline G50 and G60 S Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc. · 2004
- Descendant · 2 generations on · 932 of its ownK042770 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- Descendant · cites it directly · 930 of its ownK040502 Sonoline Ebisu Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc. · 2004
- Descendant · cites it directly · 928 of its ownK042833 Sonoline G20 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc. · 2004
Showing 5 of 1,026 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 1,026 · See all- K032111Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2003 · cites it directly955descendants
- K040060Sonoline G50 and G60 S Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc. · 2004 · cites it directly950descendants
- K042770Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2004 · 2 generations on932descendants
- K040502Sonoline Ebisu Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc. · 2004 · cites it directly930descendants
- K042833Sonoline G20 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc. · 2004 · cites it directly928descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K945773 | Siemens Sonoline Versa | Siemens Medical Solutions USA, Inc. | 1995 | — |
| 0 (this device) | K020353 | Omnia X/XS Ultrasound System | Siemens Medical Systems, Inc. | 2002 | — |
| +1 | K032111 | Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2003 | 1 |
| +1 | K040060 | Sonoline G50 and G60 S Diagnostic Ultrasound Systems | Siemens Medical Solutions USA, Inc. | 2004 | — |
| +2 | K042770 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2004 | 1 |
| +1 | K040502 | Sonoline Ebisu Diagnostic Ultrasound Systems | Siemens Medical Solutions USA, Inc. | 2004 | — |
| +1 | K042833 | Sonoline G20 Diagnostic Ultrasound Systems | Siemens Medical Solutions USA, Inc. | 2004 | — |
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 |
|---|---|---|
| 2003 | 3 | 0 |
| 2004 | 8 | 0 |
| 2005 | 10 | 0 |
| 2006 | 7 | 0 |
| 2007 | 14 | 0 |
| 2008 | 13 | 0 |
| 2009 | 18 | 0 |
| 2010 | 20 | 0 |
| 2011 | 29 | 0 |
| 2012 | 36 | 0 |
| 2013 | 46 | 0 |
| 2014 | 48 | 0 |
| 2015 | 60 | 0 |
| 2016 | 63 | 0 |
| 2017 | 78 | 0 |
| 2018 | 68 | 0 |
| 2019 | 51 | 0 |
| 2020 | 76 | 0 |
| 2021 | 55 | 0 |
| 2022 | 60 | 0 |
| 2023 | 59 | 0 |
| 2024 | 66 | 0 |
| 2025 | 83 | 2 |
| 2026 | 55 | 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 |
|---|---|---|---|
| * | K945773 | Siemens Sonoline VersaSummary page 1…90-IYN Ultrasonic Pulsed Echo Imaging System FR # 892.1560 Product Code 90-1YO Diagnostic Ultrasound Transducer FR # 892.1570 Product Code 90-ITX 3. Predicate Device: K945773, 8/7/95, cleared as the Versa, marketed as the SONOLINE Versa/Versa Pro/Versa Plus/ Omnia with subsequent modifications. K945072… | 1995 |
| * | K945072 | Siemens Q4000Summary page 1…oduct Code 90-ITX 3. Predicate Device: K945773, 8/7/95, cleared as the Versa, marketed as the SONOLINE Versa/Versa Pro/Versa Plus/ Omnia with subsequent modifications. K945072, 11/21/95, cleared as Q4000, marketed as SONOLINE Elegra/Elegra Advances/Antares with subsequent modifications. 4, Device Descr… | 1995 |
What descends from it? (1,026)
See all 1,0269 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K032111 | Acuson CV70 Cardiovascular System | 2003 | 955 |
| K040060 | Sonoline G50 and G60 S Diagnostic Ultrasound Systems | 2004 | 950 |
| K040502 | Sonoline Ebisu Diagnostic Ultrasound Systems | 2004 | 930 |
| K042833 | Sonoline G20 Diagnostic Ultrasound Systems | 2004 | 928 |
| K030949 | Titan High Resolution Ultrasound System | 2003 | 683 |
| K043559 | Sonosite High-Resolution Diagnostic Ultrasound System (C3 Series) | 2005 | 678 |
| K063761 | Acuson P10 Diagnostic Ultrasound System | 2007 | 135 |
| K043452 | Titan High Resolution Ultrasound System and Sonosite Ultrasound System | 2004 | 11 |
| K071314 | Sonoline G20 Diagnostic Ultrasound Systems | 2007 | 0 |
Has anything in its family been recalled? (2 Class I)
No FDA recall names this device.
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?
Diagnostic imaging or fluid flow analysis of the human body as follows:
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/K020353 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020353: Omnia X/XS 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/K020353
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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