# K013994: Modification to Viewsend Medical

- Pathway: 510(k) (Special)
- Applicant: Klt Telecom, Inc.
- Decided: Feb 1, 2002 after 59 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: 1 generation back to K962225 (1996). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962225: Viewsend Medical Model 1200, Klt Telecom, Inc. (1996) Summary page 1.

## Indications for use
When installed on an appropriate PC-based platform, VIEWSEND Medical software is intended to provide the medical professional with the capability to view, retrieve, store, import, process, collaborate, and/or transmit medical images in order to render a diagnosis. Options allow for teleradiology, telemedicine, videoconferencing, collaboration, DICOM 3.0, communications, viewer, customizable database, stand-alone or client/server or web-based, compression, or security. Communications between systems can be performed over wireless/wired LAN, ISDN, T1, ATM, satellite, and/or plain old telephone system (POTS). The DICOM 3.0 option allows for query, retrieve, send, receive, print, or DICOM Dir actions with DICOM 3.0 compliant modalities or server:

Source page: https://510kreport.com/device/K013994
Methodology: https://510kreport.com/methodology
