510(k) K022292 ยท LLZ System, Image Processing, Radiological
IMPAX DIAGNOSTIC DISPLAY STATION,IMPAX CLINICAL REVIEW STATION,IMPAX FOR CARDIOLOGY CLINICAL REVIEW SATATION,IMPAX ORTHO
| Applicant | Agfa Corp., Brevard NC, US |
| Decision | Substantially Equivalent, Sep 12, 2002 |
| Received | Jul 15, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K022292
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 24, 2011 | AGFA Corp. IMPAX 6.5 Client Software.
IMPAX 6.5 combines the traditional activities of RIS informatics management with PACS image management to provide a powerful platform for imaging-based planning, interpreta Terminated |
LLZ | None listed |
| Sep 8, 2009 | AGFA Corp. Agfa Impax R6.3 DB Server.
Impax Systems are Picture Archiving and Communication systems (PACs). PAC systems are used in the acceptance, transfer, display, storage and digital processing of medical 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 |
| Sep 4, 2008 | AGFA Corp. Impax 6.x Clients including: 6.3 all versions below 6.3.1 SU5, 6.2 all versions below 6.2.1 SU14 and 6.0 all versions. The Impax Systems are Picture Archiving and Communications system (PACs). PAC s Terminated |
LLZ | None listed |
| Jul 2, 2008 | AGFA Corp. Impax 4.5, Impax 5.0, Impax 5.2 and Impax 5.2x Picture Archiving Systems (PACs) with integrated Voxar 3D software; and Impax 5.0 and Impax 5.2 PACs with integrated MediCAD software. The softwares ar Terminated |
LLZ | None listed |
| Oct 12, 2006 | AGFA Corp. IMPAX 5.2 Systems with CAD Capability (Computer Assisted Diagnosis) Terminated |
LLZ | None listed |
| Jul 27, 2006 | AGFA Corp. IMPAX 4.5 Systems, used in the acceptance, transfer, display, storage and digital processing of medical images. Terminated |
LLZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.