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Realtime 3D Diagnostic Workstation

by Siemens Medical Solutions USA, Inc.

510(k) K973010

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 NumberK973010 Date10 Nov 1997ClearedStatusActive

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  • Withdrawn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, 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.

The Realtime 3D Diagnostic Workstation is a system for image processing in radiology. It is designed to process and display medical images in three dimensions for diagnostic purposes.

This workstation is manufactured by Siemens Medical Solutions USA, Inc. and is supplied as a Class II device with special controls. It is not specified as single-use or reusable, and no information regarding sterility, MRI safety, or storage conditions is provided. The device received FDA 510(k) clearance with K-number K973010 in 1997.

Other devices from Siemens Medical Solutions USA, Inc.

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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 the Realtime 3D Diagnostic Workstation used for?

    The Realtime 3D Diagnostic Workstation is a system designed for image processing in radiology. It processes and displays medical images in three dimensions to assist clinicians with diagnostic purposes.

  • How is the Realtime 3D Diagnostic Workstation supplied?

    The workstation is supplied as a Class II device with special controls by Siemens Medical Solutions USA, Inc. It is not specified as single-use or reusable, and no information regarding sterility is provided.

  • What regulatory approval does the Realtime 3D Diagnostic Workstation have?

    The device received FDA 510(k) clearance with K-number K973010 in 1997. It was determined to be substantially equivalent to other legally marketed devices.

  • Are there different models or sizes of the Realtime 3D Diagnostic Workstation?

    The device data does not specify different models or sizes of the Realtime 3D Diagnostic Workstation. The information provided focuses on its general functionality and regulatory status.