# K983447: Wise (II) Image Management System

- Pathway: 510(k) (Special)
- Applicant: Sectra-Imtec AB
- Decided: Oct 29, 1998 after 29 days
- Product code: LMB (Device, Digital Image Storage, Radiological)
- Device class: 1
- Regulation: 21 CFR 892.2010
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K922164 (1993). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K971451: Wise Image Management System, O Tech, Inc. (1997) Summary page 1.

## Most influential descendants
- K992426: Raypax Web Clinical System (1999), 0 descendants of its own

## Recalls of this device
- Feb 16, 2005 · Not classified · Z-0695-05: Failure to update correctly when re-transmitting an image from the modality.
- Jun 27, 2003 · Not classified · Z-1125-03: If DICOM fields for body part, description or accession number are changed, change won't update on the EasyWeb client or hospital systems.
- Feb 13, 2002 · Not classified · Z-1223-03: Potential display of an incorrect body part description on patient images.

## Indications for use
The Sectra WISE Image Management System device is intended for the management and displaying of x-ray images, other radiological objects, and information. It can manage images from different modalities, single and multiple file servers, and interfaces to various Radiological Information Systems (RIS), image storage and printing devices using DICOM or similar interface standards. 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/K983447
Methodology: https://510kreport.com/methodology