# K033712: Modification to Sectra IDS5 Radiology Workstation - Version 10.1

- Pathway: 510(k) (Special)
- Applicant: Sectra-Imtec AB
- Decided: Dec 23, 2003 after 27 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
No predicates in its family tree.
442 later devices descend from it; 5 cite it directly.
0 of 443 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K003308: Microlife Digital Infrared Ear Thermometer, IR1DAI, IR1DB1, IR1DD1, Microlife Corp. (2000). Our reading of the summary gave K003308, FDA’s number for Microlife Digital Infrared Ear Thermometer, IR1DAI… (Microlife Corp.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Sectra IDS5 Radiology Workstation - Version 10.1”. Kept off the family tree. Summary page 1.

## Most influential descendants
- K040376: Sectra IDS5 Radiology Workstation; Sectra MPR Package; Sectra 3D Package (2004), 439 descendants of its own
- 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

## Indications for use
The Sectra IDS device is intended for the manipulation and displaying of x-ray 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. 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/K033712
Methodology: https://510kreport.com/methodology