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Aquarius Workstation

FDA 510(k)

Class II (US FDA 510(k))

510(k) K011142

by Terarecon Inc.

Identifiers

510(k) Number
K011142 FDA 510(k)
FDA Product Code
LLZ FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 892.2050 FDA 510(k)
Regulation Number
892.2050 FDA 510(k)
Advisory Committee
Radiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

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.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Aquarius Workstation Intuition Edition User Manual - TeraRecon, PDF AquariusAPS User Guide_4.4.14.pdf, Medical software module - Aquarius iNtuition - TeraRecon - for ..., AQUARIUS WORKSTATION (K011142) — FDA 510(k) | Innolitics, Aquarius Workstation Intuition Edition User Manual - TeraRecon

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Terarecon Inc.
FDA Applicant
Terarecon,Inc.

Sources (1)

  • FDA 510(k) K011142 24 fields · synced Sep 19, 2026