# K113027: Syngo Aortic Valveguide Software

- Pathway: 510(k) (Special)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Nov 22, 2011 after 42 days
- Product code: OWB (Interventional Fluoroscopic X-Ray System)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K954355 (1995). 7 ancestors in all.
15 later devices descend from it; 2 cite it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011447: IN Space 3D, Siemens Medical Solutions USA, Inc. (2001) Summary page 2.

## Most influential descendants
- K123585: Syngo, CT Cardiac Function (2012), 14 descendants of its own
- K183268: AI-Rad Companion (Cardiovascular) (2019), 11 descendants of its own
- K210085: HealthCCSng (2021), 9 descendants of its own
- K230223: iCAC Device (2023), 6 descendants of its own
- K243229: Bunkerhill AVC (2025), 3 descendants of its own

## Recalls of this device
- Aug 29, 2016 · Class II · Z-0045-2017: 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

## Indications for use
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)

Source page: https://510kreport.com/device/K113027
Methodology: https://510kreport.com/methodology