# K063093: Sectra Workstation, Version 11.1

- Pathway: 510(k) (Special)
- Applicant: Sectra Imtec AB
- Decided: Nov 7, 2006 after 28 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K033712 (2003). 4 ancestors in all.
34 later devices descend from it; 3 cite it directly.
0 of 39 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051315: Modification to: Sectra IDS5 Workstation, Sectra Imtec AB (2005) Summary page 1.

## Most influential descendants
- K073272: Workstationone Breast Imaging Workstation (2007), 27 descendants of its own
- 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

## Recalls of this device
- Jan 30, 2009 · Not classified · Z-0412-2011: Review by firm of Philips EasyVision MM workstations found that to assure compliance with 21 CFR 900.12(c)(5) corrected software was needed so that all sites are in compliance.

## Indications for use
The Sectra Workstation is intended for the manipulation and displaying of medical images, including mammograms. It can show images from different modalities and interfaces to various image storage and printing devices using DICOM or similar interface standards. Device options make possible mammography reading, telecommunications; fast demonstration; prosthesis CAD; 3-D and angiography, etc.; and teleconferencing. Lossy compressed mammographic images are not intended for diagnostic review Mammographic images should only be viewed with a monitor approved by FDA for viewing mammographic images. For primary diagnosis, post process DICOM "for presentation" images must be used. Typical users of this system are trained professionals, including but not limited to physicians, radiologists, nurses, medical technicians, and assistants.

Source page: https://510kreport.com/device/K063093
Methodology: https://510kreport.com/methodology