# K033088: Sectra IDS5 Radiology Workstation Version 10.1

- Pathway: 510(k) (Special)
- Applicant: Sectra AB
- Decided: Oct 29, 2003 after 30 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: 1 generation back to K002936 (2000). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002936: Modification to IDS5 Image Display System, Sectra-Imtec AB (2000)

## Recalls of this device
- Jul 1, 2006 · Not classified · Z-1353-06: Potential for measurements, lines, texts, etc to be stored incorrectly.

## Indications for use
The Sectra IDS device is intended for the manipulation and displayng of x-ray images. 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 telecommunications; fast demonstration; prosthesis CAD; 3-D and angiography, etc.; and teleconferencing. 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/K033088
Methodology: https://510kreport.com/methodology