# K991643: IDS4 V3.2 Image Display System

- Pathway: 510(k) (Special)
- Applicant: O Tech, Inc.
- Decided: Jun 8, 1999 after 26 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: 3 generations back to K920950 (1992). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K971368: IDS4 Image Display System Series, O Tech, Inc. (1997) Summary page 1.

## Indications for use
The Sectra IDS4 device is intended for the manipulation and displaying 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/K991643
Methodology: https://510kreport.com/methodology