# Syngo Aortic Valveguide Software

> Active: United States. Medical device record on deviCERTS, compiled from public registries.

- Canonical page: <https://devicerts.com/devices/syngo-aortic-valveguide-software-owb>
- Manufacturer: [Siemens Medical Solutions USA, Inc.](https://devicerts.com/manufacturers/siemens-medical-solutions-usa-inc) (United States)
- Name in the registry: SYNGO AORTIC VALVEGUIDE SOFTWARE
- Device class: Class II (US FDA)
- FDA product code: OWB

## Registrations and authorizations

- **510(k)** · FDA 510(k) · United States · K113027 · decision 2011-11-22 · decision SESE · status: Active

## Recalls

- Z-0045-2017 · Class II · terminated · initiated 2016-08-29 · matched through shared submission K113027, may concern other models: 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

## Identifiers

- 510(k) Number: K113027 [FDA 510(k)]
- FDA product code: OWB [FDA 510(k)]

## Classification

- Device class: Class II [FDA 510(k)]
- Regulation: 21 CFR Part 892.1650 [FDA 510(k)]
- Advisory committee: Radiology [FDA 510(k)]
- FDA decision: SESE [FDA 510(k)]

## Source and citation

- Cite as: Syngo Aortic Valveguide Software, Siemens Medical Solutions USA, Inc. deviCERTS medical device catalogue. https://devicerts.com/devices/syngo-aortic-valveguide-software-owb (data as of 2026-11-15).
- Data sources: [FDA 510(k)](https://open.fda.gov/apis/device/510k/), [FDA recalls](https://open.fda.gov/apis/device/recall/)
- Registry records last synced: 2026-10-22
- Statuses computed as of: 2026-11-15
- JSON: <https://devicerts.com/devices/syngo-aortic-valveguide-software-owb.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/devices/syngo-aortic-valveguide-software-owb
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.