# K073272: Workstationone Breast Imaging Workstation

- Pathway: 510(k) (Traditional)
- Applicant: Three Palm Software, LLC
- Decided: Dec 11, 2007 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: 5 generations back to K904519 (1991). 17 ancestors in all.
27 later devices descend from it; 2 cite it directly.
0 of 45 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033400: Seno Advantage, Ge Medical Systems W-400 (2003) Summary page 1.
- K040468: Cedara I-Softview and Cedara I-Readmammo, Cedara Software Corp. (2004) Summary page 1.
- K063093: Sectra Workstation, Version 11.1, Sectra Imtec AB (2006) Summary page 1.

## Most influential descendants
- K082483: Quantra (2008), 25 descendants of its own
- K102556: Volpara, Version 1.3 (2010), 24 descendants of its own
- K132742: M-VU Breast Density (2013), 11 descendants of its own
- K152028: Volpara Imaging Software (2015), 8 descendants of its own
- K170540: DM-Density (2018), 7 descendants of its own

## Indications for use
The WorkstationOneTM Breast Imaging Workstation is intended for use with a regionally approved digital mammography system. The workstation displays images from multiple modalities, which include X-ray mammography MG, breast US and breast MRI. The workstation allows selection, display, manipulation, quantification, markup, print composition and media exchange of breast images. Here, quantification refers to measurements (such as area and distance) within a region of interest that the radiologist manually draws on the images. Similarly, markup refers to graphics that are manually drawn by the radiologist to indicate a region of interest. Note that the region of interest is not automatically generated by the computer. The WorkstationOneTM Breast Imaging Workstation is intended for softcopy reading and interpretation of digital mammography images by Radiologists. The WorkstationOneTM Breast Imaging Workstation when used for interpretation of images acquired using a FFDM image acquisition system shall display the images only on FDA-cleared high-resolution monitors. The images used for primary diagnostic reading must be in a lossless format, unless lossy formats are approved for use in digital mammography.

Source page: https://510kreport.com/device/K073272
Methodology: https://510kreport.com/methodology