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AGFA Corp.

56 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
AGFA Digital Radiography X-Ray system DX-D 100 Agfa's DX-D 100 is indicated for use in pro recall (Z-2081-2014)AGFA Corp.2014-07-21
IMPAX CV Pediatric Echo Reporting, IMPAX CV Echo Measurement Import via Optical Character recall (Z-1662-2014)AGFA Corp.2014-05-27
IMPAX RIS QDOC 5.8 recall (Z-0919-2014)AGFA Corp.2014-02-03
IMPAX 5.2 DB Server (running Oracle 10.1.0.4.0), medical imaging Picture Archiving and Com recall (Z-0035-2014)AGFA Corp.2013-10-21
AGFA Digital Radiography X-Ray System DX-D 100 Agfa's DX-D 100 is indicated for use in pro recall (Z-1487-2013)AGFA Corp.2013-06-06
IMPAX CV 7.8 SU3 - OCR Service. The IMPAX CV Reporting component facilitates the quick , e recall (Z-1069-2013)AGFA Corp.2013-04-08
IMPAX CV Reporting Cardiac Catheterization module and IMPAX CV Outbound Reporting. Facilit recall (Z-1070-2013)AGFA Corp.2013-04-08
CR MD1.0 General Set, x-ray imager image plate. CR 10-X Image Plate 35CM X 43CM. An image recall (Z-0970-2013)AGFA Corp.2013-03-19
AGFA IMPAC CV DICOMStore with Media Purge Daemon (MPD) and IMPAX CV DICOMStore with Cardio recall (Z-2252-2012)AGFA Corp.2012-08-22
IMPAX Cardiovascular (CV) Reporting Reporting tool used for structured reporting and struc recall (Z-2184-2012)AGFA Corp.2012-08-10
IMPAX CV Reporting The Results Management (RM)/IMPAX CV reporting component facilitates th recall (Z-2069-2012)AGFA Corp.2012-07-24
Agfa DX-D Imaging Package - (The detector power cables described in the Report of Correcti recall (Z-1062-2012)AGFA Corp.2012-02-19
Agfa Computed Radiography Systems with DX-G Digitizer. DX-G Digitizers haved the same inte recall (Z-0591-2012)AGFA Corp.2012-01-11
Curix Opthos H, size 35x43 cm A radiographic medical x-ray film designed to optimize diagn recall (Z-0285-2012)AGFA Corp.2011-11-25
IMPAX CardioVascular (CV) Admin Tool The IMPAX Cardiovascular suite is a cardiovascular in recall (Z-0272-2012)AGFA Corp.2011-11-23
IMPAX Cardiovascular Results Management (RM) Software Versions RM 2.04.37.04 to RM 7.8 SU2 recall (Z-0211-2012)AGFA Corp.2011-11-18
IMPAX CV Echo Measurement Import via Optical Character Recognition (OCR) The IMPAX Cardiov recall (Z-0212-2012)AGFA Corp.2011-11-18
IMPAX CV (Cardio Vascular) The IMPAX Cardiovascular suite is a cardiovascular information recall (Z-2552-2011)AGFA Corp.2011-06-10
IMPAX 6.5 Client Software. IMPAX 6.5 combines the traditional activities of RIS informatic recall (Z-2246-2011)AGFA Corp.2011-05-24
NX is the radiographer's image identification and quality control tool. It offers a broad recall (Z-2137-2011)AGFA Corp.2011-05-04
IMPAX Remote Cardiology Review Station, a cardiovascular information system. Model Number recall (Z-1676-2011)AGFA Corp.2011-03-16
IMPAX CV Results Manager/Results Manager Administration Tool The IMPAX Cardiovascular suit recall (Z-1435-2011)AGFA Corp.2011-02-25
Cardiovascular Review Station The IMPAX Cardiovascular suite is a cardiovascular informati recall (Z-1434-2011)AGFA Corp.2011-02-24
Mammography Keypad Radiologists and Technologist apply hotkeys from a keyboard for ease of recall (Z-0835-2011)AGFA Corp.2010-12-29
DX-G Digitizer, manufactured by Agfa-Gevart NV, Mortsel, Belgium. recall (Z-0464-2011)AGFA Corp.2010-11-26
IMPAX CV Results Manager/Results Manager Administration Tool recall (Z-2112-2010)AGFA Corp.2010-07-29
19" Barco MFCD 1219 (Touch Screen) + Low Profile Stand and Rack with LCD Arm Agfa's Comput recall (Z-2100-2010)AGFA Corp.2010-07-26
DT2 Mammo, Size 8 x 10 inch, Ref No. E2RN6. Agfa Corporation. Greenville, SC 29601. Intend recall (Z-1799-2010)AGFA Corp.2010-06-11
AGFA IMPAX HeartStation ECG Management System. recall (Z-0366-2010)AGFA Corp.2009-11-18
Agfa Impax R6.3 DB Server. Impax Systems are Picture Archiving and Communication systems ( recall (Z-1887-2009)AGFA Corp.2009-09-08
NX 2008 Central Monitoring System (CMS). Product code: E2FB6 Agfa's Computed Radiography S recall (Z-1889-2009)AGFA Corp.2009-09-02
IMPAX Cardiovascular Polling Procedure version 1.00.09, used in IMPAX 6.2.1 and 6.3.1.; Ca recall (Z-0945-2009)AGFA Corp.2009-02-03
Drystar AXYS, Hardcopy Printer A free standing device used to print diagnostic conventiona recall (Z-2136-2008)AGFA Corp.2008-09-18
IMPAX 4.1, IMPAX 4.5, IMPAX 5.0, IMPAX 5.1 IMPAX 5.2, IMPAX 6.0, IMPAX 6.2; Picture Archiv recall (Z-1243-2008)AGFA Corp.2008-09-11
WEB1000 Versions 3.1, 4.1 and 5.1, Picture Archiving and Communications systems (PACs), us recall (Z-1244-2008)AGFA Corp.2008-09-11
IMPAX 6.2.1 System, Picture Archiving and Communications system (PAC), used in the accepta recall (Z-1245-2008)AGFA Corp.2008-09-11
Impax 6.x Clients including: 6.3 all versions below 6.3.1 SU5, 6.2 all versions below 6.2. recall (Z-2180-2008)AGFA Corp.2008-09-04
Impax 4.5, Impax 5.0, Impax 5.2 and Impax 5.2x Picture Archiving Systems (PACs) with integ recall (Z-1307-2008)AGFA Corp.2008-07-02
IMPAX 6.2.1 Network Gateway Server, License Key. Catalog # ABC code: EXEGE000. The product recall (Z-1306-2008)AGFA Corp.2008-07-01
Agfa HeartLab Cardiovascular DICOMstore Version 2.04.40.00 software, Heartlab, Inc., Weste recall (Z-1241-2008)AGFA Corp.2008-06-27
Agfa Heartlab Cardiovascular Results Management Product: Versions 2.03 and 2.04. Heartlab, recall (Z-1242-2008)AGFA Corp.2008-06-27
Agfa IMPAX CardioVascular Suite Results Management Nuclear Reporting Module, Outbound Repo recall (Z-1349-2008)AGFA Corp.2008-03-31
CR NX Modality Workstation, Computed Radiography System (Software versions NX 1.0.2402 and recall (Z-0219-2007)AGFA Corp.2006-11-28
CR DX-S, Image Intensified Fluoroscopic X-ray system. recall (Z-0031-2007)AGFA Corp.2006-10-12
IMPAX 5.2 Systems with CAD Capability (Computer Assisted Diagnosis) recall (Z-0033-2007)AGFA Corp.2006-10-12
IMPAX 4.5 Systems, used in the acceptance, transfer, display, storage and digital processi recall (Z-1256-06)AGFA Corp.2006-07-27
CR DX-S, DX-S, Computed radiography system (Digitizer) recall (Z-0855-06)AGFA Corp.2006-05-09
Mamoray HDR-C PLUS Mammography film recall (Z-0788-06)AGFA Corp.2006-04-22
Cronex 10T, 14x17, Medical Screen Film, X-ray Film, 100 Sheet Box recall (Z-0754-06)AGFA Corp.2006-04-11
Curix Ultra UV-L Plus, Medical Screen Film, X-ray Film, 14x17, 100 Sheet Box recall (Z-0755-06)AGFA Corp.2006-04-11
Radiomat SG, 11x14, Medical Screen Film, X-ray Film, 100 Sheet Box and 14x17, 100 Sheet Bo recall (Z-0756-06)AGFA Corp.2006-04-11
Agfa Cronex 10T Radiographic film recall (Z-0471-06)AGFA Corp.2006-02-04
ADC Solo & Initia CR 1000, Path Speed CR SP1001, Centricity CR SP1001 and Centricity CR SP recall (Z-0352-06)AGFA Corp.2006-01-06
CR QS (versions 3.0.207, 2.0.210 SU1, 3.0.229) ADC QS and Centricity CR Online Processing recall (Z-0353-06)AGFA Corp.2006-01-06
Radiomat Lightweight Cassettes recall (Z-1404-05)AGFA Corp.2005-08-25
SCOPIX LR 5200P Laser Imagers, Type 8394/600, serial numbers between 4000 and 5266. recall (Z-0207-04)AGFA Corp.2003-12-11

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Every clearance here is in the API, with alerts when new ones post.