ClearanceBrief
510(k) K050228 ยท LLZ System, Image Processing, Radiological

AGFA HEARTLAB CARDIOVASCULAR

ApplicantHeartlab, Inc., Westerly RI, US
DecisionSubstantially Equivalent, Feb 18, 2005
ReceivedFeb 1, 2005
TypeSpecial
FDA recordOpen on fda.gov

Recalls that name K050228

DateFirm and productCodeLinked 510(k)
Dec 22, 2016AGFA 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
LLZNone listed
Sep 1, 2015AGFA 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
LLZNone listed
May 27, 2014AGFA 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
LLZNone listed
Apr 8, 2013AGFA 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
LLZNone listed
Apr 8, 2013AGFA Corp.
IMPAX CV Reporting Cardiac Catheterization module and IMPAX CV Outbound Reporting. Facilitates digital reports for catheterization, echocardiography, and congenital heart disease.
Terminated
LLZNone listed
Aug 22, 2012AGFA Corp.
AGFA IMPAC CV DICOMStore with Media Purge Daemon (MPD) and IMPAX CV DICOMStore with Cardiovascular Purge Services (CPS), Medical Image Storage Device
Terminated
LLZNone listed
Aug 10, 2012AGFA Corp.
IMPAX Cardiovascular (CV) Reporting Reporting tool used for structured reporting and structured report outputs (including XML style sheet customization and PDF)
Terminated
LLZNone listed
Jul 24, 2012AGFA 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
LLZNone listed
Nov 23, 2011AGFA 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
LLZNone listed
Nov 18, 2011AGFA 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
LLZNone listed
Nov 18, 2011AGFA 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
LLZNone listed
Jun 10, 2011AGFA 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
LLZNone listed
Mar 16, 2011AGFA Corp.
IMPAX Remote Cardiology Review Station, a cardiovascular information system. Model Number CV7.8
Terminated
LLZNone listed
Feb 25, 2011AGFA 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
LLZNone listed
Feb 24, 2011AGFA 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
LLZNone listed
Jul 29, 2010AGFA Corp.
IMPAX CV Results Manager/Results Manager Administration Tool
Terminated
LLZNone listed
Feb 3, 2009AGFA 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
LLZNone listed
Sep 11, 2008AGFA 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
LLZNone listed
Sep 11, 2008AGFA 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
LLZNone listed
Jun 27, 2008AGFA 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
LLZNone listed
Jun 27, 2008AGFA Corp.
Agfa Heartlab Cardiovascular Results Management Product: Versions 2.03 and 2.04. Heartlab, Inc., Westerly, Rhode Island 02891
Terminated
LLZNone listed
Mar 31, 2008AGFA 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
LLZNone listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.