# K040376: Sectra IDS5 Radiology Workstation; Sectra MPR Package; Sectra 3D Package

- Pathway: 510(k) (Special)
- Applicant: Sectra-Imtec AB
- Decided: May 4, 2004 after 77 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.
439 later devices descend from it; 7 cite it directly.
0 of 441 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
- K043216: Cadstream Version 4.0 (2005), 263 descendants of its own
- K050846: B-Cad System, Version 1.0 (2005), 123 descendants of its own
- K042313: Integradweb MPR/Mip (2004), 114 descendants of its own
- K141620: RS80A Diagnostic Ultrasound System (2014), 101 descendants of its own
- K143089: WS80A Diagnostic Ultrasound System (2014), 99 descendants of its own

## Indications for use
The Sectra IDS5 device 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. 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/K040376
Methodology: https://510kreport.com/methodology