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syngo.via MI Workflows VB40A Scenium

by Siemens Medical Soultions USA, Inc.

510(k) K191309

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK191309 Date19 Jul 2019ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
LLZ
Device Class
Class II
Regulation
21 CFR Part 892.2050
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

syngo.via MI Workflows VB40A Scenium is a medical diagnostic application designed for the visualization, manipulation, and comparison of multimodality medical images. It integrates functional data, such as PET or SPECT, alongside anatomical datasets like CT or MR, enabling comprehensive image analysis and rendering. The software is tailored for neurology workflows, facilitating detailed examination of multimodal imaging data.

This software is supplied as a standalone component within the syngo.via MI Workflows platform and is intended for use in clinical diagnostic settings. It is not classified as single-use or reusable, and no sterility or MRI safety information is specified. The device holds FDA 510(k) clearance under K191309, with no explicit details on storage or regulatory restrictions beyond its authorized use in radiology diagnostics.

Other devices from Siemens Medical Soultions USA, Inc.

Questions

AI-generated answers, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What types of medical images can the syngo.via MI Workflows VB40A, Scenium integrate and analyze together?

    The syngo.via MI Workflows VB40A, Scenium integrates functional imaging data like PET (Positron Emission Tomography) or SPECT (Single Photon Emission Computed Tomography) with anatomical datasets such as CT (Computed Tomography) or MR (Magnetic Resonance) scans. This integration allows clinicians to perform comprehensive multimodality analysis and visualization, particularly tailored for neurology workflows.

  • Is this software designed for single-use or reusable applications in a clinical setting?

    The syngo.via MI Workflows VB40A, Scenium is not classified as single-use or reusable. It is intended as a standalone software component within the syngo.via MI Workflows platform for continuous use in clinical diagnostic settings, where it enables ongoing visualization and analysis of multimodal medical images.

  • How is this software supplied, and what platform does it belong to?

    The syngo.via MI Workflows VB40A, Scenium is supplied as a standalone component within the broader syngo.via MI Workflows platform. It is not a physical device but rather a diagnostic application designed to enhance multimodality image analysis, particularly for neurology-related workflows.

  • What regulatory pathway was followed for FDA clearance of this software?

    The syngo.via MI Workflows VB40A, Scenium received FDA clearance through a 510(k) submission (K191309), classified under the product code LLZ and reviewed by the Radiology (RA) advisory committee. The clearance was granted under a Special 510(k) pathway, with the device deemed substantially equivalent to a predicate.