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syngo.MR Applications VB80

by Siemens Healthineers AG

510(k) K253495

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 · Traditional NumberK253495 Date20 Nov 2025ClearedStatusActive

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  • Withdrawn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, 18 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.MR Applications VB80 is an image processing software system designed for magnetic resonance imaging (MRI) workflows. It enhances MRI data acquisition, reconstruction, and post-processing to improve diagnostic accuracy and efficiency in radiology applications. The system integrates with MRI scanners to optimize image quality and support specialized imaging techniques.

This software is supplied as a standalone application for use in radiology departments equipped with MRI systems. It is intended for single-use per imaging session, though the underlying software may be installed on a dedicated workstation or networked environment. The device holds FDA 510(k) clearance under product code LLZ, classified as a Class 2 Radiology device, and is regulated under the Traditional 510(k) pathway. No sterility or reusable components are specified, as it operates as software on compatible hardware.

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Questions

AI-generated answers, 18 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 MRI workflows is syngo.MR Applications (VB80) designed to enhance, and how does it improve diagnostic accuracy?

    syngo.MR Applications (VB80) is specifically designed to optimize MRI workflows by improving data acquisition, reconstruction, and post-processing. It integrates with MRI scanners to enhance image quality and support specialized imaging techniques, which collectively help radiologists achieve clearer, more detailed diagnostic images. This leads to more accurate interpretations and more efficient radiology workflows.

  • Is syngo.MR Applications (VB80) intended for use on any MRI scanner, or does it require specific hardware compatibility?

    syngo.MR Applications (VB80) is supplied as a standalone software system intended for use with MRI scanners, but it is designed to integrate with compatible MRI systems. While the exact hardware requirements are not detailed, it is typically installed on a dedicated workstation or networked environment within radiology departments. Compatibility is assumed with Siemens MRI systems, though verification with the manufacturer is recommended for specific setups.

  • How is syngo.MR Applications (VB80) supplied, and is it reusable across multiple imaging sessions?

    syngo.MR Applications (VB80) is supplied as a software application for single-use per imaging session, though the underlying software installation itself is reusable across multiple sessions on a dedicated workstation or network. This means the software license allows for repeated use in different imaging sessions, but each session’s data processing is treated as a distinct workflow. There are no reusable physical components or sterility considerations, as it operates purely as software.

  • What regulatory pathway was used for FDA clearance of syngo.MR Applications (VB80), and how does this classification impact its use?

    syngo.MR Applications (VB80) received FDA clearance under the Traditional 510(k) pathway and is classified as a Class 2 Radiology device with product code LLZ. This classification means it is subject to general controls and special controls for radiology devices, ensuring it meets performance standards for MRI workflow optimization without requiring the stringent premarket approval process. The clearance indicates it is deemed substantially equivalent to a predicate device already on the market.

  • Does syngo.MR Applications (VB80) require any special storage conditions, and is it compatible with networked systems?

    syngo.MR Applications (VB80) is a software solution, so it does not require physical storage conditions like temperature or humidity controls. It is designed to be installed on a dedicated workstation or integrated into a networked environment within radiology departments. While the software itself does not degrade over time, compatibility and performance depend on maintaining the underlying hardware and system requirements specified by Siemens Healthineers.