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Aquarius Workstation

by Terarecon Inc.

510(k) K011142

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

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK011142 Date8 May 2001ClearedStatusActive

Official records

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  • Withdrawn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
FDA applicant
Terarecon,Inc.
Device class
Class II
Regulation
21 CFR Part 892.2050
Advisory committee
Radiology
FDA decision
SESE Substantially Equivalent

Related clearances

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

Overview

AI-generated summary, 19 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 Aquarius Workstation is a medical imaging software platform designed for the processing, analysis, and visualization of radiologic images, including those from CT, MRI, and other modalities. It integrates advanced algorithms for image reconstruction, segmentation, and quantitative analysis to support diagnostic and treatment planning workflows in radiology.

This device is supplied as a software module for use on compatible workstations and is intended for single-user operation within radiology departments or imaging centers. It operates as a standalone application with no inherent sterility requirements, though its performance may be influenced by system configuration and network connectivity. The Aquarius Workstation holds an FDA 510(k) clearance under product code LLZ, with no specific MRI safety classification noted in the regulatory submission.

Devices cleared under K011142

2 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K011142
UDI-DISize and differences
iNtuition Aquarius iNtuition Client
Terarecon Inc.
Aquarius iNtuition ClientINTUITION1 —On the market
Intuition Client
Terarecon Inc.
Intuition ClientINTUITION8 —On the market

Similar devices

Other devices filed under FDA product code LLZ (System, Image Processing, Radiological).

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