# K971451: Wise Image Management System

- Pathway: 510(k) (Traditional)
- Applicant: O Tech, Inc.
- Decided: Jun 26, 1997 after 66 days
- Product code: LMB (Device, Digital Image Storage, Radiological)
- Device class: 1
- Regulation: 21 CFR 892.2010
- 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 K922164 (1993). 2 ancestors in all.
2 later devices descend 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)
- K963395: Imageserver 2000 Picture Archiving System, Sectra-Imtec AB (1996) Summary page 1.

## Most influential descendants
- K983447: Wise (II) Image Management System (1998), 1 descendant of its own
- K992426: Raypax Web Clinical System (1999), 0 descendants of its own

## Indications for use
The SECTRA AB, 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/K971451
Methodology: https://510kreport.com/methodology