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syngo VSim

by Siemens Medical Solutions USA, Inc.

510(k) K151887

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 NumberK151887 Date16 Sep 2015ClearedStatusActive

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  • Withdrawn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
MUJ
Device class
Class II
Regulation
21 CFR Part 892.5050
Advisory committee
Radiology
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 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 VSim is a radiation therapy treatment planning system. It is classified as a Class II medical device under regulation number 892.5050.

The device received FDA 510(k) clearance (K151887) on September 16, 2015, and is manufactured by Siemens Medical Solutions USA, Inc. It is used in radiology applications for treatment planning purposes.

Other devices from Siemens Medical Solutions USA, Inc.

See all devices from Siemens Medical Solutions USA, Inc. →

Questions

AI-generated answers, 24 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 is syngo VSim used for?

    syngo VSim is a radiation therapy treatment planning system used in radiology applications for planning radiation therapy treatments, as stated in its device description and intended use.

  • How is syngo VSim supplied or distributed?

    The device data does not specify how syngo VSim is supplied, distributed, or packaged; therefore, no information about physical delivery, media, or installation method is provided in the authorization records.

  • Is syngo VSim a single-use or reusable device?

    syngo VSim is a software-based treatment planning system, not a physical implant or disposable item, so the concepts of single-use or reuse do not apply; it is designed for repeated use in clinical planning workflows.

  • What sizes or models are available for syngo VSim?

    The device data does not list specific sizes, models, or versions of syngo VSim beyond the name and K151887 clearance; no variations or configurations are detailed in the provided specifications.

  • What are the storage requirements for syngo VSim?

    Storage requirements are not addressed in the device data; as a software system, syngo VSim would typically require standard IT infrastructure conditions, but no specific environmental or storage conditions are provided in the authorization records.