# K051586: Viewsend Medical System

- Pathway: 510(k) (Traditional)
- Applicant: Kenei Co., Ltd.
- Decided: Aug 4, 2005 after 50 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
The indications for use of the VIEWSEND Medical System, as described in its labeling, are the same as the previously cleared devices marketed and distributed by KLT telecom, Inc. (K-962225). The VIEWSEND Medical System has the same intended use as the originally cleared device. When installed on an appropriate PC-based platform, the VIEWSEND Medical System is intended to provide the medical professional with the capability to compare, manipulate, annotate, collaborate, and/or transmit medical images in order to render a diagnosis. Digital image storage in system RAM and hard drive standard is with lossless compression or without data compression. Options include teleradiology, telemedicine, videoconferencing, communications, viewer, customizable database, DICOM 3.0, stand-alone or client/server or web-based, compression, and/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 servers. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Megapixel resolution and meets other technical specifications reviewed and accepted by FDA

Source page: https://510kreport.com/device/K051586
Methodology: https://510kreport.com/methodology