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syngo.via View&GO (Version VA10A)

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K182208

by Siemens Healthcare GmbH

Identifiers

510(k) Number
K182208 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 View&GO (Version VA10A) is a Medical Imaging Software designed for post-processing and visualization of radiological images. It enables radiologists and clinicians to review, annotate, and share diagnostic imaging studies in a streamlined digital workflow, supporting efficient interpretation and collaboration across healthcare settings.

This software is supplied as a standalone application for use on compatible medical imaging workstations and is intended for single-user or multi-user environments within radiology departments or diagnostic imaging centers. It is not a sterile device and is classified under the Medical Device Regulation (MDR) and holds FDA 510(k) clearance (K182208) for radiology applications. No specific sterility or single-use requirements apply, as it is a reusable software solution.

Frequently asked questions

What types of medical imaging studies can syngo.via View&GO support for review and analysis?

syngo.via View&GO is designed to support the post-processing and visualization of radiological images, enabling radiologists and clinicians to review and analyze a wide range of imaging studies. While the exact modalities aren’t specified, its FDA 510(k) clearance under the Radiology advisory committee (RA) suggests compatibility with common radiology applications such as X-rays, CT scans, MRIs, and ultrasounds. The software streamlines workflows for interpretation and collaboration, making it suitable for standard diagnostic imaging workflows in radiology departments or imaging centers.

Is syngo.via View&GO intended for single-user or multi-user environments, and how is it supplied?

syngo.via View&GO is supplied as a standalone software application and is explicitly designed for use in both single-user and multi-user environments. It is intended for installation on compatible medical imaging workstations within radiology departments or diagnostic imaging centers. Since it is not a physical device, it does not require sterility or single-use considerations—it is a reusable software solution that enhances workflow efficiency for radiologists and clinicians.

How does syngo.via View&GO facilitate collaboration among healthcare providers?

syngo.via View&GO enables radiologists and clinicians to annotate, review, and share diagnostic imaging studies in a digital format, which directly supports collaboration across healthcare settings. The software’s design emphasizes streamlined workflows, allowing teams to collectively interpret images, add notes, and communicate findings—reducing delays and improving diagnostic accuracy in shared or distributed environments like radiology departments or multi-site imaging networks.

What regulatory pathways does syngo.via View&GO follow, and how does that affect its use?

syngo.via View&GO holds FDA 510(k) clearance (K182208) under the Radiology advisory committee, confirming it meets U.S. regulatory standards for radiology applications. It is also compliant with the Medical Device Regulation (MDR) in the EU. Since it is classified as a software-based medical imaging tool rather than a physical device, its regulatory status does not impose sterility or single-use requirements—only that it adheres to software validation and safety standards for clinical use in radiology workflows.

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 View&GO - Siemens Healthineers, syngo.via View&GO - Siemens Healthineers USA, K182208 - syngo.via View&GO (Version VA10A) - Radiology, syngo.via View&GO (Version VA10A) (K182208) — FDA 510 (k) | Innolitics

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Siemens Healthcare GmbH

Sources (2)

  • FDA 510(k) K182208 24 fields · synced Oct 6, 2026
  • EUDAMED 1 fields · synced May 19, 2026