# K041581: Compacs, Version 1.0

- Pathway: 510(k) (Traditional)
- Applicant: Intelligent Images Srl
- Decided: Jun 22, 2004 after 8 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: 5 generations back to K941322 (1995). 30 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012093: Aetmed Image Processing Software, Aetmed, S.P.A. (2001) Summary page 2.
- K023112: Prosolv Cardivascular Viewer; Analyzer; Server; Version 2.5.9, Problem Solving Concepts, Inc. (2002) Summary page 2.
- K040546: Image-Arena and Research-Arena Applications, Tomtec Imaging Systems GmbH (2004) Summary page 2.
- K022940: IN-Vision View with Measurements Module, Model 1.0, Intelligent Images Srl (2002) Summary page 2.

## Most influential descendants
- K120514: Cardiopacs (2012), 0 descendants of its own

## Indications for use
ComiPACS is a software device intended to be used by qualified medical professionals, after proper installation on an appropriate hardware platform, for capturing, retrieving, viewing, printing, processing, analyzing, reporting and communicating medical digital studies such as cardiac catheterization, echocardiography or general radiological studies. The software can be used in a variet' of network configurations ranging from a stand-alone workstation to a network of workstations connected to a ComPACS server configuration. DICOM compatible imaging devices can transfer studies directly to the ComPACS archive using DICOM network protocols or DICOM removable media.

Source page: https://510kreport.com/device/K041581
Methodology: https://510kreport.com/methodology