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InterWorks

by Avreo, Inc.

510(k) K070755

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 NumberK070755 Date8 May 2007ClearedStatusActive

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  • Withdrawn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
Device class
Class II
Regulation
21 CFR Part 892.2050
Advisory committee
Radiology
FDA decision
SESE Substantially Equivalent

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.

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.

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

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