syngo®.via protoNeo (Version VA10A)
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K161685 FDA 510(k)
- FDA Product Code
- LLZ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.2050 FDA 510(k)
- Regulation Number
- 892.2050 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
syngo.via protoNeo (Version VA10A) is a medical imaging software solution designed for the viewing, manipulation, communication, and storage of digital medical images. Classified as a Class II X-ray system, it functions as a standalone device or integrates with other syngo-based software options to enhance radiology workflows.
This software is supplied as a digital product, intended for use in radiology settings. It requires no sterility or single-use considerations and is not subject to MRI safety constraints. The device is authorized under FDA 510(k) clearance (K161685) and is regulated as a radiology-related product. Storage and use adhere to standard IT and medical imaging protocols.
Frequently asked questions
What is the primary purpose of the syngo®.via protoNeo software in a clinical setting?
The syngo®.via protoNeo (Version VA10A) is designed to streamline radiology workflows by enabling the viewing, manipulation, communication, and storage of digital medical images. It functions as a standalone imaging solution or integrates with other syngo-based software to improve efficiency in radiology departments.
Is this software single-use or reusable, and does it require sterilization?
syngo®.via protoNeo is a digital software solution supplied as a standalone product, so it is neither single-use nor reusable in the traditional sense. Since it is not a physical device requiring sterilization, no sterilization procedures apply.
How is this software authorized for use in the United States?
The syngo®.via protoNeo (Version VA10A) is authorized under the FDA’s 510(k) clearance process, specifically with clearance number K161685. It is classified as a Class II X-ray system and is intended for radiology-related use, adhering to standard regulatory pathways for medical imaging software.
What storage or environmental considerations should be taken into account when using this software?
Since syngo®.via protoNeo is a digital product, its storage and use follow standard IT and medical imaging protocols. It does not require specialized environmental controls beyond typical IT infrastructure, such as secure servers, network connectivity, and compliance with hospital IT policies.
Can this software be used in conjunction with other syngo-based systems, and how does it integrate?
Yes, the syngo®.via protoNeo is designed to integrate with other syngo-based software solutions to enhance radiology workflows. Its modular nature allows it to function as a standalone tool or complement existing systems, improving image management and communication within radiology departments.
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®.via protoNeo (Version VA10A) by SIEMENS HEALTHCARE GMBH | FDA ..., Siemens Syngo®.via protoNeo (Version Va10a) | allmed.wiki, syngo®.via protoNeo (Version VA10A) (K161685) — FDA 510 (k) | Innolitics
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K161685 | Class II | Active |
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Manufacturer
- Manufacturer
- Siemens Healthcare GmbH
Sources (1)
- FDA 510(k) K161685 24 fields · synced Oct 6, 2026