510(k) K050228 ยท LLZ System, Image Processing, Radiological
AGFA HEARTLAB CARDIOVASCULAR
| Applicant | Heartlab, Inc., Westerly RI, US |
| Decision | Substantially Equivalent, Feb 18, 2005 |
| Received | Feb 1, 2005 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K050228
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 22, 2016 | AGFA Healthcare Corp. IMPAX Cardiovascular
The IMPAX CV Reporting module consists of a database and graphical user interface (GUI) that allows users to document procedure and clinical findings as structured data, with rep Terminated |
LLZ | None listed |
| Sep 1, 2015 | AGFA Healthcare Corp. IMPAX, PACS, Picture Archive and Communications System, IMPAX CV 7.8.x and IMPAX CV 12.x. Corrects certain demographic information (Patient Name, Patient Medical Record Number and/or Accession Numbe Terminated |
LLZ | None listed |
| May 27, 2014 | AGFA Corp. IMPAX CV Pediatric Echo Reporting, IMPAX CV Echo Measurement Import via Optical Character Recognition (OCR) Service IMPAX. For the creation of digital structured reports for cardiovascular diagnostic Terminated |
LLZ | None listed |
| Apr 8, 2013 | AGFA Corp. IMPAX CV 7.8 SU3 - OCR Service.
The IMPAX CV Reporting component facilitates the quick , effective creation of digital structured reports for adult catheterization and echocardiography, pediatric ech Terminated |
LLZ | None listed |
| Apr 8, 2013 | AGFA Corp. IMPAX CV Reporting Cardiac Catheterization module and IMPAX CV Outbound Reporting.
Facilitates digital reports for catheterization, echocardiography, and congenital heart disease. Terminated |
LLZ | None listed |
| Aug 22, 2012 | AGFA Corp. AGFA IMPAC CV DICOMStore with Media Purge Daemon (MPD) and IMPAX CV DICOMStore with Cardiovascular Purge Services (CPS), Medical Image Storage Device Terminated |
LLZ | None listed |
| Aug 10, 2012 | AGFA Corp. IMPAX Cardiovascular (CV) Reporting
Reporting tool used for structured reporting and structured report outputs (including XML style sheet customization and PDF) Terminated |
LLZ | None listed |
| Jul 24, 2012 | AGFA Corp. IMPAX CV Reporting
The Results Management (RM)/IMPAX CV reporting component facilitates the quick, effective creating of digital structured reports for : adult catheterization and echocardiography, p Terminated |
LLZ | None listed |
| Nov 23, 2011 | AGFA Corp. IMPAX CardioVascular (CV) Admin Tool
The IMPAX Cardiovascular suite is a cardiovascular information system providing image archiving and image display and modality study-specific structured reporting Terminated |
LLZ | None listed |
| Nov 18, 2011 | AGFA Corp. IMPAX Cardiovascular Results Management (RM) Software Versions RM 2.04.37.04 to RM 7.8 SU2
The IMPAX Cardiovascular suite is a cardiovascular information system providing image archiving and image di Terminated |
LLZ | None listed |
| Nov 18, 2011 | AGFA Corp. IMPAX CV Echo Measurement Import via Optical Character Recognition (OCR)
The IMPAX Cardiovascular suite is a cardiovascular Information system providing image archiving and image display and modalit Terminated |
LLZ | None listed |
| Jun 10, 2011 | AGFA Corp. IMPAX CV (Cardio Vascular)
The IMPAX Cardiovascular suite is a cardiovascular information system, providing archiving, image display and modality/study specific structured reporting. Terminated |
LLZ | None listed |
| Mar 16, 2011 | AGFA Corp. IMPAX Remote Cardiology Review Station, a cardiovascular information system. Model Number CV7.8 Terminated |
LLZ | None listed |
| Feb 25, 2011 | AGFA Corp. IMPAX CV Results Manager/Results Manager Administration Tool
The IMPAX Cardiovascular suite is a cardiovascular information system providing image archiving and image display and modality study-speci Terminated |
LLZ | None listed |
| Feb 24, 2011 | AGFA Corp. Cardiovascular Review Station
The IMPAX Cardiovascular suite is a cardiovascular information system, providing image archiving, image display and modality/study specific structured reporting. Terminated |
LLZ | None listed |
| Jul 29, 2010 | AGFA Corp. IMPAX CV Results Manager/Results Manager Administration Tool Terminated |
LLZ | None listed |
| Feb 3, 2009 | AGFA Corp. IMPAX Cardiovascular Polling Procedure version 1.00.09, used in IMPAX 6.2.1 and 6.3.1.; Catalog numbers: E18R4000, L5NQJ000, L57OP000, LBCDB000, and E2ZCK000.
IMPAX Cardiovascular is a picture archiv Terminated |
LLZ | None listed |
| Sep 11, 2008 | AGFA Corp. IMPAX 4.1, IMPAX 4.5, IMPAX 5.0, IMPAX 5.1 IMPAX 5.2, IMPAX 6.0, IMPAX 6.2; Picture Archiving and Communications systems (PACs), used in the acceptance, transfer, display, storage and digital pr Terminated |
LLZ | None listed |
| Sep 11, 2008 | AGFA Corp. WEB1000 Versions 3.1, 4.1 and 5.1, Picture Archiving and Communications systems (PACs), used in the acceptance, transfer, display, storage and digital processing of medical images. Terminated |
LLZ | None listed |
| Jun 27, 2008 | AGFA Corp. Agfa HeartLab Cardiovascular DICOMstore Version 2.04.40.00 software, Heartlab, Inc., Westerly, Rhode Island 02891. The software is used in the Agfa HeartLab Cardiovascular System. Terminated |
LLZ | None listed |
| Jun 27, 2008 | AGFA Corp. Agfa Heartlab Cardiovascular Results Management Product: Versions 2.03 and 2.04. Heartlab, Inc., Westerly, Rhode Island 02891 Terminated |
LLZ | None listed |
| Mar 31, 2008 | AGFA Corp. Agfa IMPAX CardioVascular Suite Results Management Nuclear Reporting Module, Outbound Report, Model/Catalog No.: L7W1P, Software Versions: 2.04.17, 2.04.19 and 2.04.20, AGFA HealthCare, Westerly, RI Terminated |
LLZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.