510(k) · Cleared
Recalled · Class II · 2016Syngo Aortic Valveguide Software
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Medical Solutions USA, Inc. · OWB Interventional Fluoroscopic X-Ray System
Cleared on Nov 22, 2011 as substantially equivalent to K011447 (Siemens Medical Solutions USA, Inc., 2001) after a 42-day review. Its family tree reaches back 4 generations to 1995. 15 later devices descend from it. It has been recalled once.
- Decided
- Nov 22, 2011
- Review
- 42 days
- Class
- Class II
- Product code
- OWB
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 4 generations to K954355 (1995). 7 ancestors in all. 15 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK954355 Advantage Windows 3D with Navigator OptionGeneral Electric Co. · 1995
- 3 generations backK974715 Advantage 3D XRGE Medical Systems · 1998
- 2 generations backK984634 3D-AngioSiemens Medical Corp. · 1999
- 1 generation backK011447 IN Space 3DSiemens Medical Solutions USA, Inc. · 2001
- This deviceK113027 Syngo Aortic Valveguide SoftwareSiemens Medical Solutions USA, Inc. · 2011
- Descendant · cites it directly · 14 of its ownK123585 Syngo, CT Cardiac FunctionSiemens Medical Solutions USA, Inc. · 2012
- Descendant · cites it directly · 11 of its ownK183268 AI-Rad Companion (Cardiovascular)Siemens Medical Solutions USA, Inc. · 2019
- Descendant · 2 generations on · 9 of its ownK210085 HealthCCSngZebra Medical Vision, Ltd. · 2021
- Descendant · 3 generations on · 6 of its ownK230223 iCAC DeviceBunkerhill, Inc. · 2023
- Descendant · 4 generations on · 3 of its ownK243229 Bunkerhill AVCBunkerHill Health · 2025
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K123585Syngo, CT Cardiac FunctionSiemens Medical Solutions USA, Inc. · 2012 · cites it directly14descendants
- K183268AI-Rad Companion (Cardiovascular)Siemens Medical Solutions USA, Inc. · 2019 · cites it directly11descendants
- K210085HealthCCSngZebra Medical Vision, Ltd. · 2021 · 2 generations on9descendants
- K230223iCAC DeviceBunkerhill, Inc. · 2023 · 3 generations on6descendants
- K243229Bunkerhill AVCBunkerHill Health · 2025 · 4 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K954355 | Advantage Windows 3D with Navigator Option | General Electric Co. | 1995 | — |
| −3 | K974715 | Advantage 3D XR | GE Medical Systems | 1998 | — |
| −2 | K984634 | 3D-Angio | Siemens Medical Corp. | 1999 | — |
| −1 | K011447 | IN Space 3D | Siemens Medical Solutions USA, Inc. | 2001 | — |
| 0 (this device) | K113027 | Syngo Aortic Valveguide Software | Siemens Medical Solutions USA, Inc. | 2011 | — |
| +1 | K123585 | Syngo, CT Cardiac Function | Siemens Medical Solutions USA, Inc. | 2012 | — |
| +1 | K183268 | AI-Rad Companion (Cardiovascular) | Siemens Medical Solutions USA, Inc. | 2019 | — |
| +2 | K210085 | HealthCCSng | Zebra Medical Vision, Ltd. | 2021 | — |
| +3 | K230223 | iCAC Device | Bunkerhill, Inc. | 2023 | — |
| +4 | K243229 | Bunkerhill AVC | BunkerHill Health | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 2 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 4 | 0 |
| 2024 | 2 | 0 |
| 2025 | 2 | 0 |
| 2026 | 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 OWB? 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 OWB device
- #1 K251602 Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6…score 18.3 · 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 |
|---|---|---|---|
| * | K011447 | IN Space 3DSummary page 2…cial 510(k) syngo Aorlic ValveGuide Software Siemens Medical Systems, Inc. S fi E M E N S Special §10(k) Submission: Aortic ValveGulde Software 510(k) #: K011447 Clearance Date: August 3, 2001 Classification Name: Accessory to Angiographic X-Ray System Classification Panel: Radiology CFR… | 2001 |
What descends from it? (15)
See all 152 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 29, 2016 | Class II | Z-0045-2017 | Device Design | The ROI-A Anterior Delivery Device T-Handle, part number SI-ROIA-0023 has experienced binding of the rotation of the t-handle. There have been no reports of patient injury |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 16 years and passes through 4 companies; a new generation was cleared every 2.6 years on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K123585 (Siemens Medical Solutions USA, Inc., 2012) has gone furthest, with 14 descendants of its own.
- 4 other devices also cite its predicate K011447.
How does its category compare?
All OWB devicesOWB Interventional Fluoroscopic X-Ray System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · OWB
22in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OWB
148in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OWB
42so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OWB
14,008in 2025
MAUDE reports naming product code OWB, 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 | 3 | 52 | 0 | 1 |
| 2008 | 4 | 135 | 1 | 0 |
| 2009 | 9 | 99 | 0 | 0 |
| 2010 | 7 | 66 | 0 | 0 |
| 2011 | 6 | 79 | 0 | 1 |
| 2012 | 6 | 37 | 0 | 1 |
| 2013 | 11 | 119 | 10 | 27 |
| 2014 | 15 | 158 | 9 | 103 |
| 2015 | 11 | 66 | 35 | 2,134 |
| 2016 | 16 | 103 | 13 | 4,074 |
| 2017 | 20 | 76 | 13 | 1,604 |
| 2018 | 23 | 54 | 6 | 1,449 |
| 2019 | 9 | 174 | 7 | 1,558 |
| 2020 | 16 | 53 | 8 | 1,581 |
| 2021 | 24 | 60 | 31 | 1,981 |
| 2022 | 21 | 90 | 24 | 2,932 |
| 2023 | 12 | 152 | 22 | 7,604 |
| 2024 | 13 | 126 | 11 | 7,942 |
| 2025 | 22 | 148 | 30 | 14,008 |
| 2026 | 15 | 221 | 42 | — |
What is it indicated for?
The syngo Aortic ValveGuide software is an add-on option to InSpace 3D software with an enhanced algorithm to display the aortic root and to visually assist the physician by placing the C-arm in an orthogonal position to the aortic root plane.
The syngo Aortic ValveGuide software is intended for imaging soft tissues (heart) for diagnosis, surgical planning, interventional procedures and treatment follow-up.
This software is also designed to visually assist physicians in the diagnosis and treatment of vessel malformations (i.e. Aneurysms, AVM's and Stenoses)
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/K113027 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113027: Syngo Aortic Valveguide Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113027
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