# K141556: Avreo Interworks System

- Pathway: 510(k) (Special)
- Applicant: Avreo, Inc.
- Decided: Jul 2, 2014 after 20 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K924178 (1993). 21 ancestors in all.
No later device cites it as a predicate yet.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070755: Interworks, Avreo, Inc. (2007) Summary page 1.

## Indications for use
interWORKS is intended to provide a completely scalable PACS solution for hospitals and other related sites, which will distribute, retrieve archive, and display, data and Images from a variety of different modality and Information systems. This also includes the display of structured reports and mammography Images that have been created according to DICOM "For Presentation", and will Include standard features and other Mammno tools. Lossy compressed mammography Images and digitized film screen images must not be used for primary image interpretations. Mammographic images may only be interpreted using an FDA cleared display that meets technical specifications reviewed and accepted by FDA. Application areas Include Imaging centers, radiologist central reading rooms and any other locations where trained medical professionals would require access or desire patient images, demographic information or other patient medical information captured In the system.

Source page: https://510kreport.com/device/K141556
Methodology: https://510kreport.com/methodology