Heartlab Cardiovascular
510(k) K050228
Active
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK050228 | Date18 Feb 2005 | StatusActive |
Recalls
-
- Terminated 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.
-
- Terminated 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.
-
- Terminated 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.
-
- Terminated Z-1069-2013
Software design error in IMPAX CV 7.8 SU3
-
- Terminated 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) system.
-
- Terminated 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 Purge Service (CPS).
-
- Terminated Z-2184-2012
Content entered into the "Conclusions" free text box on the Report Writer screen was not represented on the final printed report.
-
- Terminated 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 representation of the report.
-
- Terminated 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.
-
- Terminated 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 (OCR).
-
- Terminated Z-0211-2012
Improper merging of IMPAX Cardiovascular Results Management (RM) reports causes the signed report to become unavailable.
-
- Terminated Z-2552-2011
Customer error with the angiography (XA: X-Ray Angiography) measurement calibration functionality within the Cardiovascular Review Station resulted in improper calibration.
-
- Terminated Z-1676-2011
A discrepancy in the validation testing which resulted in the product not performing as intended.
-
- Terminated Z-1434-2011
Echocardiography volume measurements performed within CRS were not reflected correctly in associated Results Management (RM) reports.
-
- Terminated Z-2112-2010
Agfa Service technician had incorrectly modified a report template at one site resulting in erroneous anatomic segment locators.
-
- Terminated 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.
-
- Terminated Z-0945-2009
Polling procedure may fail when multiple merge/split is carried out.
-
- Terminated 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 generated on the Nuclear Cardiology Reporting Module.
-
- Terminated Z-1242-2008
Incorrect Results: Erroneous echocardiographic measurement values due to mathematical formula being mis-configured.
-
- Terminated Z-1241-2008
MIsidentification: The electrocardiogram (ECG) data of one patient is misidentified as the data of another patient.
-
- Terminated Z-1243-2008
- Terminated 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.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Full name
- Agfa Heartlab Cardiovascular
- 510(k) Number
- FDA Product Code
- LLZ
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.2050
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 20 Sep 2026
The Heartlab Cardiovascular is a cardiovascular imaging system designed for diagnostic and analytical purposes in cardiology. It integrates ultrasound imaging modalities, including echocardiography, vascular, stress, and general ultrasound, to provide comprehensive cardiovascular assessments. The device supports real-time visualization and analysis of cardiac structures and function, aiding in the evaluation of cardiac anatomy, physiology, and pathology. Its primary function is to enhance diagnostic accuracy and workflow efficiency for clinicians specializing in cardiovascular care.
This system is intended for use in clinical settings such as hospitals and cardiology clinics, where it is employed to streamline imaging workflows from acquisition to reporting. Supplied as a software-based solution, it is installed on compatible hardware platforms and requires no sterilization or single-use considerations. The device operates within standard MRI safety guidelines for non-MRI environments, as it is not designed for use in MRI suites. Authorized for commercial distribution in the United States under FDA 510(k) clearance (K050228), it adheres to regulatory standards for diagnostic imaging devices in cardiology.
Other devices from Heartlab, Inc.
Questions
AI-generated answers, 20 Sep 2026
What types of cardiovascular imaging can the AGFA Heartlab Cardiovascular system perform, and how does it improve diagnostic workflows?
The AGFA Heartlab Cardiovascular integrates multiple ultrasound modalities, including echocardiography, vascular, stress, and general ultrasound, to provide a comprehensive assessment of cardiac structures and function. It supports real-time visualization and analysis, which helps clinicians evaluate cardiac anatomy, physiology, and pathology with greater accuracy. By streamlining workflows from image acquisition to reporting, it enhances efficiency in clinical settings like hospitals and cardiology clinics.
Is the AGFA Heartlab Cardiovascular system designed for use in MRI environments, and if not, what safety guidelines does it follow?
No, the AGFA Heartlab Cardiovascular is not designed for use in MRI suites. Instead, it operates within standard MRI safety guidelines for non-MRI environments, ensuring safe and appropriate use in clinical settings where MRI procedures are not performed.
How is the AGFA Heartlab Cardiovascular system supplied, and are there any special handling requirements like sterilization or single-use considerations?
The AGFA Heartlab Cardiovascular is supplied as a software-based solution that requires installation on compatible hardware platforms. Since it is not a physical device that comes into direct contact with patients, there are no sterilization or single-use requirements. It is intended for use in clinical environments where it is installed and maintained as part of a broader imaging infrastructure.
What regulatory pathway was followed for the commercial distribution of the AGFA Heartlab Cardiovascular in the United States?
The AGFA Heartlab Cardiovascular received FDA 510(k) clearance (K050228) for commercial distribution in the United States. This clearance was granted under a Special 510(k) review pathway, with the device deemed substantially equivalent to a predicate device, as determined by the Radiology (RA) Advisory Committee.