Syngo Virtual Cockpit VB10A
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- syngo Virtual Cockpit EUDAMEDFDA UDI
- Generic Name
- Radiology DICOM image processing application software FDA UDI
- Device Name
- MDR_05_FOR_SYNGO_SaMD_IIb EUDAMED
- Model / Reference
- MDR_05_FOR_SYNGO_SaMD_IIb EUDAMED11665703 EUDAMEDVB10A/11665703 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04056869991269 EUDAMEDFDA UDI
- Basic UDI-DI
- 0405686901978WU EUDAMED
- 510(k) Number
- K232744 FDA 510(k)
- FDA Product Code
- LLZ FDA 510(k)FDA UDI
- EMDN Code
- Z11069092 VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE EUDAMED
- GMDN Term
- Radiology DICOM image processing application software FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 892.2050 FDA 510(k)
- Regulation Number
- 892.2050 FDA 510(k)FDA UDI
- Special Device Type
- Software EUDAMED
- Market of Registration
- Germany EUDAMED
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
No
Expiration Date
No
Manufacturing Date
No
The Syngo Virtual Cockpit VB10A is a multi-vendor, multi-modality remote scanning software solution designed for radiology workflows. It facilitates virtual access to imaging expertise, enabling standardized diagnostic processes across diverse imaging systems and locations. This software integrates with existing modalities to enhance diagnostic consistency and collaboration among care teams.
Supplied as a software application, the Syngo Virtual Cockpit VB10A is intended for use in radiology departments and imaging centers. It operates on compatible IT infrastructure and does not require physical sterility or single-use considerations. The device holds FDA 510(k) clearance and MDR authorization, adhering to regulatory standards for medical software in radiology. No specific MRI safety classification or physical size constraints are noted in the specifications.
Frequently asked questions
What types of imaging systems can the Syngo Virtual Cockpit VB10A integrate with, and how does this benefit radiology workflows?
The Syngo Virtual Cockpit VB10A is a multi-vendor, multi-modality software solution designed to integrate with diverse imaging systems, regardless of manufacturer. This allows radiology departments to standardize diagnostic processes across different modalities and locations, improving consistency and enabling seamless collaboration among care teams. It doesn’t replace physical hardware but enhances workflow efficiency by providing a unified interface for remote access and review.
Is the Syngo Virtual Cockpit VB10A a single-use or reusable software solution, and what does that mean for my facility?
The Syngo Virtual Cockpit VB10A is a software application, not a physical device, so it is neither single-use nor reusable in the traditional sense. Since it runs on compatible IT infrastructure, it can be installed and used repeatedly across multiple imaging sessions and departments. This means your facility will need to ensure proper IT compatibility and licensing for ongoing use, but there are no consumable or disposal considerations like with hardware-based devices.
How is the Syngo Virtual Cockpit VB10A regulated, and what does that mean for compliance in my radiology department?
The Syngo Virtual Cockpit VB10A holds both FDA 510(k) clearance and MDR (Medical Device Regulation) authorization, confirming it meets regulatory standards for medical software in radiology. This means your department can rely on its compliance with safety and performance requirements, though you should still verify compatibility with your existing IT systems and follow Siemens Healthcare’s implementation guidelines to ensure proper integration and use within your workflow.
Does the Syngo Virtual Cockpit VB10A require any special storage conditions, and how is it delivered to my facility?
Since the Syngo Virtual Cockpit VB10A is a software solution, it is not a physical product with storage requirements like temperature or humidity constraints. It is delivered digitally—likely via download or installation media—and requires only a compatible IT environment (e.g., servers, workstations) to operate. Your facility will need to ensure the infrastructure meets Siemens Healthcare’s system requirements for installation and ongoing functionality.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: syngo Virtual Cockpit - Siemens Healthineers, syngo Virtual Cockpit - Siemens Healthineers USA, Siemens Syngo Virtual Cockpit (vb10a) - allmed.wiki
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K232744 | Class II | Active |
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Manufacturer
- Manufacturer
- Siemens Healthcare GmbH
Sources (3)
- FDA 510(k) K232744 24 fields · synced Oct 7, 2026
- FDA UDI 755cf3a5-cf26-42a6-b539-b2772191758f 33 fields · synced May 27, 2026
- EUDAMED 846136c9-9868-4ffb-b7dd-e8f8f0f0b544 61 fields · synced Jul 22, 2026