ClearanceBrief
Company ยท US

AGFA Corp.

FDA 510(k) clearances and medical device recalls filed under this name, 2000 to 2006. Name variants (Inc, Corp, punctuation) are merged.

23510(k) clearances (0 in 12 months)
57recalls (0 in 12 months)
47recalls that name a 510(k)

Product codes

CodeDeviceRecords
LLZSystem, Image Processing, Radiological40
MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)15
LMCCamera, Multi Format, Radiological8
JACSystem, X-Ray, Film Marking, Radiographic4
IWZFilm, Radiographic3
IXACassette, Radiographic Film2
IXKSystem, Imaging, X-Ray, Electrostatic2
IZLSystem, X-Ray, Mobile2
KPRSystem, X-Ray, Stationary1
LMDSystem, Digital Image Communications, Radiological1
MBQPeripheral Electromagnetic Field (Pemf) To Aid Wound Healing1
MUHSystem, X-Ray, Extraoral Source, Digital1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Nov 22, 2006K063421DX-SI
Agfa Corp.
MQB
Oct 13, 2006K062742CR 85-X
Agfa Corporation
MQB
Sep 1, 2006K062223AGFA MODEL CR30-X
Agfa Corporation
MQB
Jan 17, 2006K053634COMPUTED RADIOGRAPHY SYSTEM WITH NX 1.0 WORKSTATION
Agfa Corporation
MQB
Dec 22, 2005K053458WEB1000
Agfa Corp., CA
LLZ
Aug 31, 2005K052251DRYSTAR MODEL 5500
Agfa Corporation
LMC
Apr 21, 2005K050810AGFA CR50.0
Agfa Corp.
MQB
Apr 21, 2005K050751IMPAX ORTHOPAEDIC WORKSTATION, MODEL IMPAX ES 5.X
Agfa Corp.
LLZ
Oct 21, 2004K042779RADIOTHERAPY SOLUTION BASED ON CR
Agfa Corp.
IXK
Jul 22, 2004K041701AFGA CR25.0 COMPUTED RADIOGRAPHY SYSTEM
Agfa Corp.
MQB
May 26, 2004K040555IMPAX CLIENT EMBRACE
Agfa Corp., CA
LLZ
May 12, 2004K040344IMPAX OT3000 ORTHOPEDIC WORKSTATION
Agfa Corp., CA
LLZ
Sep 24, 2003K032635DRYSTAR 5300 MEDICAL IMAGE PRINTER, MODEL 5300
Agfa Corp.
LMC
Oct 22, 2002K023287DRYSTAR 5500
Agfa Corp.
LMC
Sep 26, 2002K023020AGFA MAMORAY MAMMOGRAPHIC CASSETTE, AGFA METAL-BODIED CAWO CASSETTE, AGFA CURIX AND LIGHTWEIGHT CASSETTE
Agfa Corp.
IXA
Sep 12, 2002K022292IMPAX DIAGNOSTIC DISPLAY STATION,IMPAX CLINICAL REVIEW STATION,IMPAX FOR CARDIOLOGY CLINICAL REVIEW SATATION,IMPAX ORTHO
Agfa Corp.
LLZ
Sep 6, 2002K022658LR DICOM CONTROLLER
Agfa Corp.
LMC
Aug 6, 2002K021542ADC DENTAL
Agfa Corp.
MUH
Nov 29, 2001K012941DRYSTAR, MODEL 4500M
Agfa Corp.
LMC
Nov 14, 2001K012750ADC PEDIATRIC
Agfa Corp.
MQB
Sep 20, 2001K012010MODIFICATION TO LR 5200 FILM RECORDER
Agfa Corp.
LMC
Mar 28, 2001K010571ADC QS/IPD WORKSTATION
Agfa Corp.
LLZ
Feb 16, 2000K000159AGFA DIAGNOSTIC CENTER ADC, ADC COMPACT, AND ADC SOLO
Agfa Corp.
IXK

Latest recalls

DateFirm and productCodeLinked 510(k)
Jul 21, 2014AGFA Corp.
AGFA Digital Radiography X-Ray system DX-D 100 Agfa's DX-D 100 is indicated for use in providing diagnostic quality images to aid the physician with diagnosis. Systems can be used with MUSICA2 image
Terminated
IZLK103597
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
LLZK050228
Feb 3, 2014AGFA Corp.
IMPAX RIS QDOC 5.8
Terminated
LLZK111945
Oct 21, 2013AGFA Corp.
IMPAX 5.2 DB Server (running Oracle 10.1.0.4.0), medical imaging Picture Archiving and Communication System (PACS).
Terminated
LLZK071297
Jun 6, 2013AGFA Corp.
AGFA Digital Radiography X-Ray System DX-D 100 Agfa's DX-D 100 is indicated for use in providing diagnostic quality images to aid the physician with diagnosis. Systems can be used with MUSICA2 image
Terminated
IZLK103597
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
LLZK050228
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
LLZK050228
Mar 19, 2013AGFA Corp.
CR MD1.0 General Set, x-ray imager image plate. CR 10-X Image Plate 35CM X 43CM. An image plate, contained in an X-Ray cassette, used to capture images from X-Ray exposures. The cassette with the im
Terminated
MQBK121948
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
LLZK050228
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
LLZK050228
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
LLZK050228
Feb 19, 2012AGFA Corp.
Agfa DX-D Imaging Package - (The detector power cables described in the Report of Correction and Removal are connected to portable detector panels used in the DX-D systems) Product Usage: DX-D Imagin
Terminated
MQBK092669
Jan 11, 2012AGFA Corp.
Agfa Computed Radiography Systems with DX-G Digitizer. DX-G Digitizers haved the same intended use as the predicate devices. they are intended to use in providing diagnostic images to aid the physici
Terminated
MQBK092238
Nov 25, 2011AGFA Corp.
Curix Opthos H, size 35x43 cm A radiographic medical x-ray film designed to optimize diagnostic chest imaging by providing complete diagnostic information including superbly visualized lung detail al
Terminated
IWZNone 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
LLZK050228
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
LLZK050228
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
LLZK050228
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
LLZK050228
May 24, 2011AGFA 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
LLZK022292
May 4, 2011AGFA Corp.
NX is the radiographer's image identification and quality control tool. It offers a broad array of features developed especially to meet the needs of the radiographer. Standard tasks are completed qui
Terminated
MQBK071162
Mar 16, 2011AGFA Corp.
IMPAX Remote Cardiology Review Station, a cardiovascular information system. Model Number CV7.8
Terminated
LLZK050228
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
LLZK050228
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
LLZK050228
Dec 29, 2010AGFA Corp.
Mammography Keypad Radiologists and Technologist apply hotkeys from a keyboard for ease of use in their clinical and diagnostic activities. The Agfa Mammography Keypad allows users the ability to appl
Terminated
LLZK081976
Nov 26, 2010AGFA Corp.
DX-G Digitizer, manufactured by Agfa-Gevart NV, Mortsel, Belgium.
Terminated
MQBK092238
Jul 29, 2010AGFA Corp.
IMPAX CV Results Manager/Results Manager Administration Tool
Terminated
LLZK050228
Jul 26, 2010AGFA Corp.
19" Barco MFCD 1219 (Touch Screen) + Low Profile Stand and Rack with LCD Arm Agfa's Computed Radiography Systems with NX2.X software are indicated for use in providing diagnostic quality images to ai
Terminated
MQBK071162
Jun 11, 2010AGFA Corp.
DT2 Mammo, Size 8 x 10 inch, Ref No. E2RN6. Agfa Corporation. Greenville, SC 29601. Intended to display mammographic images.
Terminated
LLZNone listed
Mar 2, 2010AGFA Corp.
Drystar Mammo. Display of Mammographic images.
Terminated
IWZNone listed
Nov 18, 2009AGFA Corp.
AGFA IMPAX HeartStation ECG Management System.
Terminated
LLZK050858
Sep 8, 2009AGFA 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
LLZK022292
Sep 2, 2009AGFA Corp.
NX 2008 Central Monitoring System (CMS). Product code: E2FB6 Agfa's Computed Radiography Systems with NX Workstations are intended for use in providing diagnostic quality images to aid the physicia
Terminated
LLZK090672
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
LLZK022292
K050228
Sep 18, 2008AGFA Corp.
Drystar AXYS, Hardcopy Printer A free standing device used to print diagnostic conventional and mammography images on transparent film for viewing on a standard view box. It may be used in any situa
Terminated
LMCK072680
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
LLZK022292
K040555 +3
Sep 11, 2008AGFA Corp.
IMPAX 6.2.1 System, Picture Archiving and Communications system (PAC), used in the acceptance, transfer, display, storage and digital processing of medical images.
Terminated
LLZK040555
K050751
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
LLZK022292
K040555 +3
Sep 4, 2008AGFA 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
LLZK022292
Jul 2, 2008AGFA 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
LLZK022292
Jul 1, 2008AGFA Corp.
IMPAX 6.2.1 Network Gateway Server, License Key. Catalog # ABC code: EXEGE000. The product is used to transfer medical imaging data. AGFA Corp., Greenville, South Carolina 2960.
Terminated
LMDNone listed
Jun 27, 2008AGFA Corp.
Agfa Heartlab Cardiovascular Results Management Product: Versions 2.03 and 2.04. Heartlab, Inc., Westerly, Rhode Island 02891
Terminated
LLZK050228
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
LLZK050228
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
LLZK050228
Nov 28, 2006AGFA Corp.
CR NX Modality Workstation, Computed Radiography System (Software versions NX 1.0.2402 and NX 1.0.2405).
Terminated
MBQNone listed
Oct 12, 2006AGFA Corp.
IMPAX 5.2 Systems with CAD Capability (Computer Assisted Diagnosis)
Terminated
LLZK022292
Oct 12, 2006AGFA Corp.
CR DX-S, Image Intensified Fluoroscopic X-ray system.
Terminated
MQBK050810
Jul 27, 2006AGFA Corp.
IMPAX 4.5 Systems, used in the acceptance, transfer, display, storage and digital processing of medical images.
Terminated
LLZK022292
May 9, 2006AGFA Corp.
CR DX-S, DX-S, Computed radiography system (Digitizer)
Terminated
MQBK050810
Apr 22, 2006AGFA Corp.
Mamoray HDR-C PLUS Mammography film
Terminated
IWZNone listed
Apr 11, 2006AGFA Corp.
Radiomat SG, 11x14, Medical Screen Film, X-ray Film, 100 Sheet Box and 14x17, 100 Sheet Box
Terminated
JACNone listed

Newest 50 of 57.

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