InterWorks
by Avreo, Inc.
510(k) K070755
Active
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK070755 | Date8 May 2007 | StatusActive |
Official records
- FDA 510(k) database K070755
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 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
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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