# K050228: Agfa Heartlab Cardiovascular

- Pathway: 510(k) (Special)
- Applicant: Heartlab, Inc.
- Decided: Feb 18, 2005 after 17 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: 22 (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). 11 ancestors in all.
9 later devices descend from it; 2 cite it directly.
0 of 21 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.
- K994210: Inturis Suite, Philips Medical Systems, Inc. (2000) Summary page 1.

## Most influential descendants
- K053133: Syngo Dynamics, Version 5.0 (2005), 7 descendants of its own
- K111319: Ibis Explorer and Markup Software (2011), 6 descendants of its own
- K122205: EXINI (2012), 5 descendants of its own
- K191262: aBSI (2019), 2 descendants of its own
- K211655: aPROMISE (2021), 1 descendant of its own

## Recalls of this device
- Dec 22, 2016 · Class II · Z-2652-2017: A customer experienced when using IMPAX CV Reporting software, specifically, when building a NIV report, the NIV Cardio report was showing incorrect findings for Aneurysm.
- Sep 1, 2015 · Class II · Z-0283-2016: Customers have experienced IMPAX CV software, specifically, Demographics Manager (DM), not producing correct pdf reports after the reports, at the time of physician signature, were correct.
- Apr 30, 2014 · Class II · Z-1662-2014: Failure to effectively install and test a hotfix to correct the known software defect within the IMPAX CV 7.8 SU3-OCR Service.
- Mar 15, 2013 · Class II · Z-1070-2013: Baseline pulmonary capillary wedge (PCW) pressure values from IMPAX CV Reporting Cardiac Catheterization module were not correctly transferring into the hospital's electronic health record (EHR) syste
- Mar 15, 2013 · Class II · Z-1069-2013: Software design error in IMPAX CV 7.8 SU3
- Aug 9, 2012 · Class II · Z-2252-2012: Loss of patient data can occur under certain circumstances due to misconfiguration of DICOMstore configured with Agfa's Medical Image Storage Devices - Media Purge Daemon (MPD) and Cardiovascular Purg
- Jul 27, 2012 · Class II · Z-2184-2012: Content entered into the "Conclusions" free text box on the Report Writer screen was not represented on the final printed report.
- Jul 10, 2012 · Class II · Z-2069-2012: When users selected "Left stenosis" in the "Graft Duplex Conclusion" section in IMPAX CV Reporting Non-Invasive(NIV) module, "Right stenosis" appeared in the sentence display within the printed repres
- Jun 6, 2011 · Not classified · Z-0211-2012: Improper merging of IMPAX Cardiovascular Results Management (RM) reports causes the signed report to become unavailable.
- Jun 6, 2011 · Not classified · Z-0212-2012: Incorrect entries in mapping files could lead to inaccurate measurement display in adult and pediatric echo reports when using the IMPAX CV Echo Measurement Import via Optical Character Recognition (O
- Jun 6, 2011 · Not classified · Z-0272-2012: Potential for misattribution of data and for a report to become unavailable when the user requests for it to be moved to another study that already has a report associated with it.
- Mar 21, 2011 · Not classified · Z-2552-2011: Customer error with the angiography (XA: X-Ray Angiography) measurement calibration functionality within the Cardiovascular Review Station resulted in improper calibration.
- Feb 10, 2011 · Not classified · Z-1676-2011: A discrepancy in the validation testing which resulted in the product not performing as intended.
- Jan 27, 2011 · Not classified · Z-1434-2011: Echocardiography volume measurements performed within CRS were not reflected correctly in associated Results Management (RM) reports.
- Jun 11, 2010 · Not classified · Z-2112-2010: Agfa Service technician had incorrectly modified a report template at one site resulting in erroneous anatomic segment locators.
- Apr 15, 2009 · Not classified · Z-1435-2011: User could modify a measurement's units and that change would not be reflected in echocardiography formulas used within the Adult echocardiography RM.
- Dec 24, 2008 · Not classified · Z-0945-2009: Polling procedure may fail when multiple merge/split is carried out.
- Feb 22, 2008 · Not classified · Z-1349-2008: Reporting Differences: The Outbound Report software produces an Outbound Report (text version) which does not contain all the clinical content elements present in the PDF version of the report, also g
- Jul 27, 2007 · Not classified · Z-1242-2008: Incorrect Results: Erroneous echocardiographic measurement values due to mathematical formula being mis-configured.
- Jun 21, 2007 · Not classified · Z-1241-2008: MIsidentification: The electrocardiogram (ECG) data of one patient is misidentified as the data of another patient.
- May 14, 2007 · Not classified · Z-1243-2008: Java version 1.6x (JAVA 6) is not compatible with AGFA IMPAX Administration/Service Tools. Due to a Software Mismatch data can be lost.
- May 14, 2007 · Not classified · Z-1244-2008: Java version 1.6x (JAVA 6) is not compatible with AGFA IMPAX Administration/Service Tools. Due to a Software Mismatch data can be lost.

## Indications for use
Ascentia TM (formally EncompassTM) is a picture archiving and communications system intended to be used as a networked cardiovascular information management system. AscentiaTM is personal software comprised of modular software programs that run on standard "off-the-shelf" computers and servers running the Windows 2000/2003/XP operating system. AscentiaTM 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. AscentiaTM 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/K050228
Methodology: https://510kreport.com/methodology