# K963395: Imageserver 2000 Picture Archiving System

- Pathway: 510(k) (Traditional)
- Applicant: Sectra-Imtec AB
- Decided: Oct 25, 1996 after 58 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: 1 generation back to K922164 (1993). 1 ancestor in all.
4 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K922164: Raytel Digital Imaging Systems, Olicon Imaging Systems, Inc. (1993) Summary page 1.

## Most influential descendants
- K971451: Wise Image Management System (1997), 2 descendants of its own
- K983447: Wise (II) Image Management System (1998), 1 descendant of its own
- K992426: Raypax Web Clinical System (1999), 0 descendants of its own
- K980241: Netco Medical Data Transportation Service Software (1998), 0 descendants of its own

## Indications for use
The ImageServer 2000 System will be used for digitally store images for archival together with informaton about the images.

Source page: https://510kreport.com/device/K963395
Methodology: https://510kreport.com/methodology