# K051743: R2 Breast Imaging Workstation

- Pathway: 510(k) (Traditional)
- Applicant: R2 Technology, Inc.
- Decided: Jul 25, 2005 after 26 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: 1 generation back to K033712 (2003). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033712: Modification to Sectra IDS5 Radiology Workstation - Version 10.1, Sectra-Imtec AB (2003) Summary page 1.

## Most influential descendants
- K071492: Firstview (2007), 0 descendants of its own

## Indications for use
The R2 Breast Imaging Workstation is intended for the manipulation and display of x-ray images, including the primary reading of mammograms. It can show images from different acquisition/scanning devices and interfaces to various image storage and printing devices using DICOM or similar interface standards. Typical users of this system are trained professionals, including but not limited to physicians, radiologists, nurses, medical technicians and assistants. Lossy compressed mammographic images are not intended for diagnostic review. Mammographic images should only be viewed with a monitor approved by FDA for viewing manmographic images.

Source page: https://510kreport.com/device/K051743
Methodology: https://510kreport.com/methodology