# K032157: Telemis-Medical Solution

- Pathway: 510(k) (Traditional)
- Applicant: Telemis S.A.
- Decided: Sep 24, 2003 after 72 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: 2 generations back to K942120 (1994). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013630: Isite Radiology, Stentor, Inc. (2001) Summary page 2.

## Indications for use
The Telemis-Medical solution is a software package intended for the acquisition, management, distribution and display of medical images within the healthcare system. It can be marketed as software only, as well as packaged with standard PC hardware. It was developed with the Java® technology that allows the software to run on every operating system implementing a Java Virtual Machine Environment (f.i. Windows, MacOS, Unix). It communications using the standard TCP/IP network protocol.

Source page: https://510kreport.com/device/K032157
Methodology: https://510kreport.com/methodology