# K141061: Remoteye Viewer

- Pathway: 510(k) (Traditional)
- Applicant: Neologica S.R.L.
- Decided: Aug 1, 2014 after 99 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: 4 generations back to K896095 (1990). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012211: Efilm Workstation, Efilm Medical, Inc. (2001) Summary page 4.

## Most influential descendants
- K242166: TribusConnect (2025), 0 descendants of its own

## Indications for use
The RemotEye Viewer software product is intended to be used as a fully functional, web-based medical image viewer to download, review, interpret, manipulate, visualize and print medical multi-modality image data in DICOM format, also stored in remote locations with respect to the viewing site. When interpreted by a trained physician, the medical images displayed by RemotEye Viewer can be used as an element for diagnosis. Typical users of RemotEye Viewer are trained professionals, including but not limited to radiologists, physicians, nurses and technicians.

Source page: https://510kreport.com/device/K141061
Methodology: https://510kreport.com/methodology