syngo®.via protoNeo (Version VA20)
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K173378 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 VA20) is a medical imaging software platform designed for the viewing, manipulation, communication, and storage of diagnostic images. Classified under product code LLZ, it serves as a standalone or integrated solution within radiology workflows, enabling clinicians to interpret and manage radiographic, CT, MRI, and other imaging modalities in a centralized environment.
The device is supplied as a software application, intended for use in clinical, diagnostic, and research settings where image processing and archiving are required. It is not described as single-use or reusable but operates within a regulated software environment, adhering to FDA 510(k) clearance (K173378) under the Radiology advisory committee. No sterility, MRI safety, or physical size specifications are provided in the available data.
Frequently asked questions
What clinical settings is the syngo®.via protoNeo software designed to support, and how does it integrate into existing workflows?
The syngo®.via protoNeo (Version VA20) is specifically designed for clinical, diagnostic, and research environments where radiologic imaging is used. It functions as a standalone or integrated solution within radiology workflows, allowing clinicians to view, manipulate, communicate, and store diagnostic images from modalities like X-ray, CT, MRI, and others. This centralized platform streamlines interpretation and management of imaging data, improving efficiency in environments where multi-modal imaging is standard.
Is the syngo®.via protoNeo software single-use or reusable, and what are its storage or handling requirements?
Since syngo®.via protoNeo is a software application, it is neither single-use nor reusable in the traditional sense. It operates within a regulated software environment and requires installation on a compatible computing system. The software itself does not have physical storage or handling requirements beyond standard IT infrastructure needs—such as proper server maintenance, software updates, and compliance with institutional IT policies—to ensure optimal performance and data integrity.
How is the FDA clearance for syngo®.via protoNeo determined, and what does the product code LLZ indicate about its regulatory classification?
The syngo®.via protoNeo (Version VA20) received FDA clearance via a 510(k) submission (K173378), classified as substantially equivalent to a predicate device under the Radiology advisory committee (RA). The product code LLZ categorizes it under radiologic computer software, confirming its role as a diagnostic imaging tool rather than a physical medical device. This classification aligns with its function as a platform for viewing, processing, and archiving radiographic images.
Does the syngo®.via protoNeo software require any special environmental or safety considerations, such as MRI compatibility or sterility?
The available data does not specify any sterility requirements or MRI safety considerations for syngo®.via protoNeo, as it is purely a software-based imaging platform. Since it operates on standard computing hardware, its use is limited to controlled clinical or diagnostic environments where IT infrastructure is properly maintained. No physical device components are involved, so traditional safety concerns (e.g., sterility or electromagnetic interference) do not apply.
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 VA20) 510(k) K173378 - FDA.report, 510(k) Premarket Notification, syngo®.via protoNeo (Version VA20) — FDA K173378, syngo®.via protoNeo (Version VA20) (K173378) — 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 | K173378 | Class II | Active |
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Manufacturer
- Manufacturer
- Siemens Healthcare GmbH
Sources (1)
- FDA 510(k) K173378 24 fields · synced Oct 6, 2026