# K971368: IDS4 Image Display System Series

- Pathway: 510(k) (Traditional)
- Applicant: O Tech, Inc.
- Decided: Jun 26, 1997 after 73 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: 2 generations back to K920950 (1992). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K961983: TRS 2000 Teleradiology System, Sectra-Imtec AB (1996) Summary page 1.

## Most influential descendants
- K991643: IDS4 V3.2 Image Display System (1999), 0 descendants of its own

## Indications for use
The SECTRA IIDS4 device is intended for the manipulation and displaying of x-ray images. It can show images [rom different modalitics and interfaces to various unage storage and printing devices using DICOM or similar interface standards. Device options make possible teleccommunications; fast demonstration; prosthesis CAD; 3-D and angiograplty, etc.; and teleconterencing. Typical users of this system arc trained professionals, including but not limitcd to physicians, radiologists, nurses, medical technicians, and assistants.

Source page: https://510kreport.com/device/K971368
Methodology: https://510kreport.com/methodology