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3-D Imaging Workstation

by Eigen, LLC

510(k) K081093

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 NumberK081093 Date1 May 2008ClearedStatusActive

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  • Withdrawn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, 23 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 3-D Imaging Workstation is a radiology system designed for image processing and three‑dimensional visualization of X‑ray data. It functions as a workstation that receives imaging data, reconstructs volumetric images, and provides tools for analysis and display in clinical radiology settings.

The device was cleared by the FDA in 2008 through a traditional 510(k) submission (K‑number K081093, product code LLL) and is classified as a Class II system. It is marketed by Eigen, LLC and is intended for use in radiology departments. The clearance indicates substantial equivalence to a predicate device, and the workstation is supplied as a non‑sterile, reusable unit for clinical imaging workflows.

Other devices from Eigen

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Questions

AI-generated answers, 23 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 primary function of the 3-D Imaging Workstation?

    The workstation receives raw X‑ray data, reconstructs it into three‑dimensional volumetric images, and provides analysis and display tools that support clinical interpretation in radiology departments.

  • How is the device supplied and intended to be used?

    Eigen markets the workstation as a non‑sterile, reusable unit that integrates into existing radiology workflows. It is installed in a clinical setting and used repeatedly for processing and visualizing patient imaging studies.

  • Is the 3-D Imaging Workstation a sterile product?

    No, the workstation is supplied as a non‑sterile device. Because it is a fixed imaging system rather than an implant or disposable accessory, sterility is not required for its intended use.

  • What regulatory clearance does the workstation have?

    The system received FDA 510(k) clearance in 2008 (K‑number K081093) as a Class II radiology device, indicating it is substantially equivalent to a legally marketed predicate.

  • What types of imaging data can the workstation process?

    It is designed specifically for X‑ray‑derived data, converting the acquired images into three‑dimensional reconstructions that can be examined with built‑in analysis and visualization tools.