Medical Device Manufacturer · US , Greenville , SC

Agfa Corp.

19 submissions · 19 cleared · Since 2000
19
Total
19
Cleared
0
Denied

Agfa Corp. — FDA 510(k) Submissions

Agfa Corp. has submitted 19 FDA 510(k) premarket notifications since 2000, of which 19 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include System, Image Processing, Radiological, Camera, Multi Format, Radiological, Solid State X-ray Imager (flat Panel/digital Imager), System, Imaging, X-ray, Electrostatic, System, X-ray, Extraoral Source, Digital . Use the specialty filter in the sidebar to narrow results.

19 devices
1–19 of 19
DX-SI
K063421 · MQB Solid State X-ray Imager... · Radiology
Nov 2006 9d
WEB1000
K053458 · LLZ System, Image Processing,... · Radiology
Dec 2005 9d
IMPAX ORTHOPAEDIC WORKSTATION, MODEL IMPAX ES 5.X
K050751 · LLZ System, Image Processing,... · Radiology
Apr 2005 29d
AGFA CR50.0
K050810 · MQB Solid State X-ray Imager... · Radiology
Apr 2005 21d
RADIOTHERAPY SOLUTION BASED ON CR
K042779 · IXK System, Imaging, X-ray,... · Radiology
Oct 2004 15d
AFGA CR25.0 COMPUTED RADIOGRAPHY SYSTEM
K041701 · MQB Solid State X-ray Imager... · Radiology
Jul 2004 30d
IMPAX CLIENT EMBRACE
K040555 · LLZ System, Image Processing,... · Radiology
May 2004 85d
IMPAX OT3000 ORTHOPEDIC WORKSTATION
K040344 · LLZ System, Image Processing,... · Radiology
May 2004 90d
DRYSTAR 5300 MEDICAL IMAGE PRINTER, MODEL 5300
K032635 · LMC Camera, Multi Format,... · Radiology
Sep 2003 29d
DRYSTAR 5500
K023287 · LMC Camera, Multi Format,... · Radiology
Oct 2002 20d
AGFA MAMORAY MAMMOGRAPHIC CASSETTE, AGFA METAL-BODIED CAWO CASSETTE, AGFA CURIX AND LIGHTWEIGHT CASSETTE
K023020 · IXA Cassette, Radiographic Film · Radiology
Sep 2002 15d
IMPAX DIAGNOSTIC DISPLAY STATION,IMPAX CLINICAL REVIEW STATION,IMPAX FOR CARDIOLOGY CLINICAL REVIEW SATATION,IMPAX ORTHO
K022292 · LLZ System, Image Processing,... · Radiology
Sep 2002 59d
LR DICOM CONTROLLER
K022658 · LMC Camera, Multi Format,... · Radiology
Sep 2002 28d
ADC DENTAL
K021542 · MUH System, X-ray, Extraoral... · Radiology
Aug 2002 88d
DRYSTAR, MODEL 4500M
K012941 · LMC Camera, Multi Format,... · Radiology
Nov 2001 90d
ADC PEDIATRIC
K012750 · MQB Solid State X-ray Imager... · Radiology
Nov 2001 90d
MODIFICATION TO LR 5200 FILM RECORDER
K012010 · LMC Camera, Multi Format,... · Radiology
Sep 2001 85d
ADC QS/IPD WORKSTATION
K010571 · LLZ System, Image Processing,... · Radiology
Mar 2001 30d
AGFA DIAGNOSTIC CENTER ADC, ADC COMPACT, AND ADC SOLO
K000159 · IXK System, Imaging, X-ray,... · Radiology
Feb 2000 28d
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