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InterWorks

FDA 510(k)

Class II (US FDA 510(k))

510(k) K070755

by Avreo, Inc.

Identifiers

510(k) Number
K070755 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)

InterWorks is a radiology workflow management system designed to streamline and optimize imaging department operations. It integrates with existing imaging equipment and software to enhance productivity and coordination between radiologists and technologists by automating administrative and analytical tasks.

The system is supplied as a software solution for use within radiology departments and is intended for authorized users in healthcare settings. It operates on standard IT infrastructure and does not require single-use or reusable components, sterility, or specialized storage conditions. Authorized by the FDA under 510(k) clearance (K070755), InterWorks is classified under product code LLZ and was reviewed by the Radiology Advisory Committee.

Frequently asked questions

What specific operational challenges does the InterWorks system address in radiology departments?

InterWorks is designed to streamline and optimize radiology workflows by integrating with existing imaging equipment and software. It automates administrative and analytical tasks to improve productivity and coordination between radiologists and technologists, reducing inefficiencies in scheduling, image management, and communication.

Does InterWorks require any specialized hardware or infrastructure beyond standard IT systems?

No, InterWorks is a software solution that operates on standard IT infrastructure. It does not require additional hardware, single-use components, or specialized equipment beyond what is already available in most healthcare settings.

How is the InterWorks system authorized for use in healthcare settings?

InterWorks received FDA clearance under the 510(k) pathway (K070755) and is classified under product code LLZ. The system was reviewed by the Radiology Advisory Committee (RA) and determined to be substantially equivalent to a legally marketed predicate device.

Is InterWorks intended for use in any specific clinical scenarios or procedures?

InterWorks is not intended for clinical use in patient care or procedures. Instead, it is an administrative workflow management system for radiology departments, designed to enhance operational efficiency and coordination between staff.

How is InterWorks supplied, and are there any restrictions on its use or storage?

InterWorks is supplied as a software solution and does not require physical storage conditions or restrictions. Since it is a software-based system, it is installed and used directly on authorized IT infrastructure within healthcare settings, with no need for single-use or reusable components.

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: Welcome to Avreo interWORKS, About interWORKS - Avreo, PDF MR-5050_R2_GettingToKnowAvreointerWORKS - CMS Imaging, Inc.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Avreo, Inc.

Sources (1)

  • FDA 510(k) K070755 24 fields · synced Sep 19, 2026