# K050667: R2 Family of Image Display Units with R2 Uniform Display Software

- Pathway: 510(k) (Traditional)
- Applicant: R2 Technology, Inc.
- Decided: Mar 29, 2005 after 14 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: 5 generations back to K913475 (1991). 18 ancestors in all.
No later device cites it as a predicate yet.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023003: Imagechecker-CT Workstation, R2 Technology, Inc. (2002) Summary page 1.
- K042697: Second Look Viewer, Icad, Inc. (2004) Summary page 1.
- K031248: Consultiva Report Station, Model RS-1, Miramedica, Inc. (2003) Summary page 1.
- K800751: Radx Vent-AL Mechanical Resporator, Radx Corp. (1980) Summary page 1.

## Indications for use
The family of R2 Image Display Units with UDS software is intended to display low resolution, non-diagnostic medical images with annotations such as pre-computed regions-of-interest or pre-computed CAD marks from medical scanning devices.

Source page: https://510kreport.com/device/K050667
Methodology: https://510kreport.com/methodology