510(k) · Cleared
Clearedsyngo Ultrasound Apps Suite (sUSAS)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Medical Solutions USA, Inc. · LLZ System, Image Processing, Radiological
Cleared on May 18, 2020 as substantially equivalent to K143254 (Siemens Medical Solutions USA, Inc., 2014) and 1 other predicate after a 27-day review. Its family tree reaches back 25 generations to 1995.
- Decided
- May 18, 2020
- Review
- 27 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 25 generations to K935595 (1995). 160 ancestors in all, the oldest K863700 (1987). No later device cites it as a predicate yet.
- Root · 25 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 21 generations between
- 3 generations backK171766 Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medi Cal Solutions, Inc. · 2017
- 2 generations backK181098 ACUSON SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2018
- 1 generation backK200585 Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2020
- This deviceK201062 syngo Ultrasound Apps Suite (sUSAS)Siemens Medical Solutions USA, Inc. · 2020
Show all 25 generations
- Root · 25 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 24 generations backK973767 Harmonic Imaging with ContrastAcuson Corp. · 1997
- 23 generations backK022567 Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002
- 22 generations backK032114 Sequoia 8.0 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2003
- 21 generations backK041319 Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004
- 20 generations backK042770 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- 19 generations backK050240 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 18 generations backK052894 Sonoline G60 S Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 17 generations backK063138 Modification to Acuson Antares Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006
- 16 generations backK063803 Acuson Antares Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007 · Recalled
- 15 generations backK072786 Acuson S2000 Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2007
- 14 generations backK083095 Sonixtouch Ultrasound SystemUltrasonix Medical Corporation · 2008
- 13 generations backK092271 GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3…GE Healthcare · 2009 · Recalled
- 12 generations backK110943 Logiq E9GE Healthcare · 2011 · Recalled
- 11 generations backK113690 GE Logiq I, Logiq E and Vivid EGE Healthcare · 2011 · Recalled
- 10 generations backK121699 Acuson X300 Diagnostic Ultrasound System Sonovista X300 Diagnostic…Siemens Medical Solutions USA, Inc. · 2012
- 9 generations backK123622 AcusonSiemens Medical Solutions USA, Inc. · 2012 · Recalled
- 8 generations backK130754 Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medi Cal Solutions, Inc. · 2013
- 7 generations backK132654 Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. Ultrasound Gro · 2013
- 6 generations backK142628 Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medi Cal Solutions, Inc. · 2014
- 5 generations backK162221 ACUSON SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions Inc. Ultrasound Group · 2016 · Recalled
- 4 generations backK170315 Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medi Cal Solutions, Inc. · 2017 · Recalled
- 3 generations backK171766 Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medi Cal Solutions, Inc. · 2017
- 2 generations backK181098 ACUSON SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2018
- 1 generation backK200585 Acuson SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2020
- This deviceK201062 syngo Ultrasound Apps Suite (sUSAS)Siemens Medical Solutions USA, Inc. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −25 | K935595 | Acuson Model 3001 | Acuson Corp. | 1995 | — |
| −24 | K973767 | Harmonic Imaging with Contrast | Acuson Corp. | 1997 | — |
| −23 | K022567 | Sequoia Signature II Diagnostic Ultrasound System | Acuson Corp. | 2002 | — |
| −22 | K032114 | Sequoia 8.0 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2003 | — |
| −21 | K041319 | Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −20 | K042770 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2004 | 1 |
| −19 | K050240 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −18 | K052894 | Sonoline G60 S Ultrasound System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −17 | K063138 | Modification to Acuson Antares Ultrasound System | Siemens Medical Solutions USA, Inc. | 2006 | — |
| −16 | K063803 | Acuson Antares Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2007 | 9 |
| −15 | K072786 | Acuson S2000 Ultrasound System | Siemens Medical Solutions USA, Inc. | 2007 | — |
| −14 | K083095 | Sonixtouch Ultrasound System | Ultrasonix Medical Corporation | 2008 | — |
| −13 | K092271 | GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4 | GE Healthcare | 2009 | 1 |
| −12 | K110943 | Logiq E9 | GE Healthcare | 2011 | 2 |
| −11 | K113690 | GE Logiq I, Logiq E and Vivid E | GE Healthcare | 2011 | 1 |
| −10 | K121699 | Acuson X300 Diagnostic Ultrasound System Sonovista X300 Diagnostic Ultrasound… | Siemens Medical Solutions USA, Inc. | 2012 | — |
| −9 | K123622 | Acuson | Siemens Medical Solutions USA, Inc. | 2012 | 13 |
| −8 | K130754 | Acuson SC2000 Diagnostic Ultrasound System | Siemens Medi Cal Solutions, Inc. | 2013 | — |
| −7 | K132654 | Acuson SC2000 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. Ultrasound Gro | 2013 | — |
| −6 | K142628 | Acuson SC2000 Diagnostic Ultrasound System | Siemens Medi Cal Solutions, Inc. | 2014 | — |
| −5 | K162221 | ACUSON SC2000 Diagnostic Ultrasound System | Siemens Medical Solutions Inc. Ultrasound Group | 2016 | 1 |
| −4 | K170315 | Acuson SC2000 Diagnostic Ultrasound System | Siemens Medi Cal Solutions, Inc. | 2017 | 1 |
| −3 | K171766 | Acuson SC2000 Diagnostic Ultrasound System | Siemens Medi Cal Solutions, Inc. | 2017 | — |
| −2 | K181098 | ACUSON SC2000 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2018 | — |
| −1 | K200585 | Acuson SC2000 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2020 | — |
| 0 (this device) | K201062 | syngo Ultrasound Apps Suite (sUSAS) | Siemens Medical Solutions USA, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1989 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 4 | 0 |
| 1995 | 5 | 0 |
| 1996 | 1 | 0 |
| 1997 | 6 | 0 |
| 1998 | 2 | 0 |
| 1999 | 7 | 0 |
| 2000 | 7 | 0 |
| 2001 | 9 | 0 |
| 2002 | 10 | 0 |
| 2003 | 10 | 0 |
| 2004 | 15 | 0 |
| 2005 | 12 | 0 |
| 2006 | 8 | 0 |
| 2007 | 8 | 0 |
| 2008 | 10 | 0 |
| 2009 | 6 | 0 |
| 2010 | 5 | 0 |
| 2011 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2017 | 2 | 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 LLZ? 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 LLZ device
- #1 K230955 syngo Application Softwarescore 21.6 · 11 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 |
|---|---|---|---|
| * | K143254 | eSie Apps SuiteSummary page 5…ary Predicate 510(k) Number / Clearance Substantial Equivalence Device Date / ProCode claimed to: eSie Apps Suite (Primary K143254 / 12/10/2014 / Syngo® Ultrasound Apps Predicate) Suite VA17A image display,… | 2014 |
| * | K200585 | Acuson SC2000 Diagnostic Ultrasound System Cleared while this submission was under review Summary page 5…processing using the same CAPS. ACUSON SC2000 K200585 / 04/22/2020 / IYO ACUSON SC2000 Diagnostic Ultrasound Diagnostic Ultrasound System (v5.1… | 2020 |
| † | K171053 | syngo Dynamics Version VA30 | 2017 |
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 25 years and passes through 8 companies; a new generation was cleared every 10 months on median.
- 43 of the 160 ancestors have a recall of any class.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · LLZ
58in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LLZ
173in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LLZ
11in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LLZ
116in 2025
MAUDE reports naming product code LLZ, 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 | 76 | 36 | 20 | 152 |
| 2008 | 94 | 52 | 32 | 154 |
| 2009 | 70 | 62 | 21 | 145 |
| 2010 | 51 | 98 | 17 | 145 |
| 2011 | 106 | 79 | 30 | 454 |
| 2012 | 82 | 87 | 12 | 266 |
| 2013 | 95 | 84 | 64 | 1,130 |
| 2014 | 78 | 89 | 6 | 15,631 |
| 2015 | 64 | 90 | 16 | 211 |
| 2016 | 82 | 90 | 12 | 290 |
| 2017 | 78 | 107 | 5 | 104 |
| 2018 | 104 | 105 | 7 | 72 |
| 2019 | 74 | 107 | 2 | 88 |
| 2020 | 81 | 115 | 6 | 82 |
| 2021 | 83 | 116 | 3 | 70 |
| 2022 | 65 | 137 | 4 | 28 |
| 2023 | 87 | 157 | 8 | 26 |
| 2024 | 62 | 131 | 6 | 42 |
| 2025 | 58 | 173 | 11 | 116 |
| 2026 | 45 | 110 | 14 | — |
What is it indicated for?
The syngo® Ultrasound Apps Suite is a software-only product to be run on a user's PACS (Picture Archiving and Communications System) workstation. It is intended to launch Siemens’ CAPs (Clinical Applications Packages) for image processing, including the acceptance, transfer, display and digital processing of ultrasound images. Digital processing includes image manipulation and quantification on a workstation. Use of a clinical application package by a qualified clinician can add information to the study to be used for a clinical diagnosis.
The software supports the following clinical application packages:
• eSie Volume Viewer
• eSie LVA
• eSie PISA
• eSie Valves
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K201062 · printed Nov 3, 2026
Cite this page
510(k) Report. “K201062: syngo Ultrasound Apps Suite (sUSAS).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K201062
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