# K040896: Modification to Encompass

- Pathway: 510(k) (Traditional)
- Applicant: Heartlab, Inc.
- Decided: Jul 16, 2004 after 101 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K913475 (1991). 12 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022292: Impax Diagnostic Display Station,Impax Clinical Review Station,Impax for Cardiology Clinical Review Satation,Impax Ortho, Agfa Corp. (2002) Summary page 1.
- K954860: Echonet, Heartlab, Inc. (1995) Summary page 1.
- K994210: Inturis Suite, Philips Medical Systems, Inc. (2000) Summary page 1.

## Most influential descendants
- K053043: Encompass Software Package (2005), 0 descendants of its own

## Recalls of this device
- Jul 23, 2008 · Not classified · Z-0543-2009: If the text is manually modified and additional phrases added as a result of worksheet interactions, some of the phrases may not populate the report.

## Indications for use
EncompassTM is a picture archiving and communications system intended to be used as a networked cardiovascular information management system. EncompassTM is software comprised of modular software programs that run on standard "off-the-shelf' personal computers and servers running the Windows 2000/XP operating system. EncompassT M is image data storage and display software that accepts DICOM (Digital Imaging and Communications in Medicine) data from laboratories, which support DICOM standard imaging transfer. The system provides the capability to; consolidate images generated by equipment from multiple OEM vendors, view images, enter clinical findings while viewing the associated images, perform digital subtraction, create graphical representation of coronary arteries, perform quantitative measurements on both cath and ultrasound images, perform quantitative analysis on cath images, generate and review patient reports with additional measurement and report writer capabilities and provides accessible digital image archive. EncompassTM is a scalable network system designed to service customers ranging in size from small departments (with 2 or 3 users) to large hospital networks (with tens of users).

Source page: https://510kreport.com/device/K040896
Methodology: https://510kreport.com/methodology