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Isg 3DMV Workstation

by I.S.G. Technologies, Inc. 510(k)

Active United States

510(k) K901679

Overview

The Isg 3DMV Workstation is a medical imaging system, specifically a Class II CT scanner. It is used in radiology for diagnostic purposes. The device provides 3D imaging capabilities, enhancing the ability to visualize and diagnose medical conditions.

The Isg 3DMV Workstation is supplied by I.S.G. Technologies, Inc. and has received FDA 510(k) clearance, indicated by the clearance number K901679. The device is intended for use in a clinical setting, with storage and use guidelines following standard medical imaging equipment protocols. The workstation is designed for use in radiology departments, with its regulatory clearance status documented across relevant authorities.

AI-generated from registry data, 27 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK901679 Date29 May 1990ClearedStatusActive

Coverage

1 jurisdiction

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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

Full name
Resubmitted Isg 3DMV Workstation
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

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Questions

  • What is the ISG 3DMV Workstation used for?

    The ISG 3DMV Workstation is used in radiology for diagnostic purposes, providing 3D imaging capabilities to visualize and diagnose medical conditions.

  • Is the ISG 3DMV Workstation cleared for use?

    Yes, the ISG 3DMV Workstation has received FDA 510(k) clearance, indicated by the clearance number K901679, and is intended for use in a clinical setting.

  • How should the ISG 3DMV Workstation be stored and used?

    The ISG 3DMV Workstation should be stored and used following standard medical imaging equipment protocols, and is designed for use in radiology departments.