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
| Code | Device | Records |
|---|---|---|
| LLZ | System, Image Processing, Radiological | 40 |
| MQB | Solid State X-Ray Imager (Flat Panel/Digital Imager) | 15 |
| LMC | Camera, Multi Format, Radiological | 8 |
| JAC | System, X-Ray, Film Marking, Radiographic | 4 |
| IWZ | Film, Radiographic | 3 |
| IXA | Cassette, Radiographic Film | 2 |
| IXK | System, Imaging, X-Ray, Electrostatic | 2 |
| IZL | System, X-Ray, Mobile | 2 |
| KPR | System, X-Ray, Stationary | 1 |
| LMD | System, Digital Image Communications, Radiological | 1 |
| MBQ | Peripheral Electromagnetic Field (Pemf) To Aid Wound Healing | 1 |
| MUH | System, X-Ray, Extraoral Source, Digital | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 22, 2006 | K063421 | DX-SI Agfa Corp. | MQB |
| Oct 13, 2006 | K062742 | CR 85-X Agfa Corporation | MQB |
| Sep 1, 2006 | K062223 | AGFA MODEL CR30-X Agfa Corporation | MQB |
| Jan 17, 2006 | K053634 | COMPUTED RADIOGRAPHY SYSTEM WITH NX 1.0 WORKSTATION Agfa Corporation | MQB |
| Dec 22, 2005 | K053458 | WEB1000 Agfa Corp., CA | LLZ |
| Aug 31, 2005 | K052251 | DRYSTAR MODEL 5500 Agfa Corporation | LMC |
| Apr 21, 2005 | K050810 | AGFA CR50.0 Agfa Corp. | MQB |
| Apr 21, 2005 | K050751 | IMPAX ORTHOPAEDIC WORKSTATION, MODEL IMPAX ES 5.X Agfa Corp. | LLZ |
| Oct 21, 2004 | K042779 | RADIOTHERAPY SOLUTION BASED ON CR Agfa Corp. | IXK |
| Jul 22, 2004 | K041701 | AFGA CR25.0 COMPUTED RADIOGRAPHY SYSTEM Agfa Corp. | MQB |
| May 26, 2004 | K040555 | IMPAX CLIENT EMBRACE Agfa Corp., CA | LLZ |
| May 12, 2004 | K040344 | IMPAX OT3000 ORTHOPEDIC WORKSTATION Agfa Corp., CA | LLZ |
| Sep 24, 2003 | K032635 | DRYSTAR 5300 MEDICAL IMAGE PRINTER, MODEL 5300 Agfa Corp. | LMC |
| Oct 22, 2002 | K023287 | DRYSTAR 5500 Agfa Corp. | LMC |
| Sep 26, 2002 | K023020 | AGFA MAMORAY MAMMOGRAPHIC CASSETTE, AGFA METAL-BODIED CAWO CASSETTE, AGFA CURIX AND LIGHTWEIGHT CASSETTE Agfa Corp. | IXA |
| Sep 12, 2002 | K022292 | IMPAX DIAGNOSTIC DISPLAY STATION,IMPAX CLINICAL REVIEW STATION,IMPAX FOR CARDIOLOGY CLINICAL REVIEW SATATION,IMPAX ORTHO Agfa Corp. | LLZ |
| Sep 6, 2002 | K022658 | LR DICOM CONTROLLER Agfa Corp. | LMC |
| Aug 6, 2002 | K021542 | ADC DENTAL Agfa Corp. | MUH |
| Nov 29, 2001 | K012941 | DRYSTAR, MODEL 4500M Agfa Corp. | LMC |
| Nov 14, 2001 | K012750 | ADC PEDIATRIC Agfa Corp. | MQB |
| Sep 20, 2001 | K012010 | MODIFICATION TO LR 5200 FILM RECORDER Agfa Corp. | LMC |
| Mar 28, 2001 | K010571 | ADC QS/IPD WORKSTATION Agfa Corp. | LLZ |
| Feb 16, 2000 | K000159 | AGFA DIAGNOSTIC CENTER ADC, ADC COMPACT, AND ADC SOLO Agfa Corp. | IXK |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 21, 2014 | AGFA 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 |
IZL | K103597 |
| 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 | K050228 |
| Feb 3, 2014 | AGFA Corp. IMPAX RIS QDOC 5.8 Terminated |
LLZ | K111945 |
| Oct 21, 2013 | AGFA Corp. IMPAX 5.2 DB Server (running Oracle 10.1.0.4.0), medical imaging Picture Archiving and Communication System (PACS). Terminated |
LLZ | K071297 |
| Jun 6, 2013 | AGFA 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 |
IZL | K103597 |
| 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 | K050228 |
| 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 | K050228 |
| Mar 19, 2013 | AGFA 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 |
MQB | K121948 |
| 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 | K050228 |
| 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 | K050228 |
| 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 | K050228 |
| Feb 19, 2012 | AGFA 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 |
MQB | K092669 |
| Jan 11, 2012 | AGFA 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 |
MQB | K092238 |
| Nov 25, 2011 | AGFA 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 |
IWZ | 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 | K050228 |
| 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 | K050228 |
| 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 | K050228 |
| 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 | K050228 |
| 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 | K022292 |
| May 4, 2011 | AGFA 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 |
MQB | K071162 |
| Mar 16, 2011 | AGFA Corp. IMPAX Remote Cardiology Review Station, a cardiovascular information system. Model Number CV7.8 Terminated |
LLZ | K050228 |
| 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 | K050228 |
| 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 | K050228 |
| Dec 29, 2010 | AGFA 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 |
LLZ | K081976 |
| Nov 26, 2010 | AGFA Corp. DX-G Digitizer, manufactured by Agfa-Gevart NV, Mortsel, Belgium. Terminated |
MQB | K092238 |
| Jul 29, 2010 | AGFA Corp. IMPAX CV Results Manager/Results Manager Administration Tool Terminated |
LLZ | K050228 |
| Jul 26, 2010 | AGFA 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 |
MQB | K071162 |
| Jun 11, 2010 | AGFA Corp. DT2 Mammo, Size 8 x 10 inch, Ref No. E2RN6. Agfa Corporation. Greenville, SC 29601.
Intended to display mammographic images. Terminated |
LLZ | None listed |
| Mar 2, 2010 | AGFA Corp. Drystar Mammo.
Display of Mammographic images. Terminated |
IWZ | None listed |
| Nov 18, 2009 | AGFA Corp. AGFA IMPAX HeartStation ECG Management System. Terminated |
LLZ | K050858 |
| 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 | K022292 |
| Sep 2, 2009 | AGFA 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 |
LLZ | K090672 |
| 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 | K022292 K050228 |
| Sep 18, 2008 | AGFA 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 |
LMC | K072680 |
| 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 | K022292 K040555 +3 |
| Sep 11, 2008 | AGFA 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 |
LLZ | K040555 K050751 |
| 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 | K022292 K040555 +3 |
| 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 | K022292 |
| 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 | K022292 |
| Jul 1, 2008 | AGFA 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 |
LMD | 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 | K050228 |
| 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 | K050228 |
| 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 | K050228 |
| Nov 28, 2006 | AGFA Corp. CR NX Modality Workstation, Computed Radiography System (Software versions NX 1.0.2402 and NX 1.0.2405). Terminated |
MBQ | None listed |
| Oct 12, 2006 | AGFA Corp. IMPAX 5.2 Systems with CAD Capability (Computer Assisted Diagnosis) Terminated |
LLZ | K022292 |
| Oct 12, 2006 | AGFA Corp. CR DX-S, Image Intensified Fluoroscopic X-ray system. Terminated |
MQB | K050810 |
| Jul 27, 2006 | AGFA Corp. IMPAX 4.5 Systems, used in the acceptance, transfer, display, storage and digital processing of medical images. Terminated |
LLZ | K022292 |
| May 9, 2006 | AGFA Corp. CR DX-S, DX-S, Computed radiography system (Digitizer) Terminated |
MQB | K050810 |
| Apr 22, 2006 | AGFA Corp. Mamoray HDR-C PLUS Mammography film Terminated |
IWZ | None listed |
| Apr 11, 2006 | AGFA Corp. Radiomat SG, 11x14, Medical Screen Film, X-ray Film, 100 Sheet Box and 14x17, 100 Sheet Box Terminated |
JAC | None listed |
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