Medical Device Manufacturer · US , Greenville , SC

Agfa Corp. - FDA 510(k) Cleared Devices

19 submissions · 19 cleared · Since 2000
19
Total
19
Cleared
0
Denied
FDA 510(k) Regulatory Record - Agfa Corp. Radiology
19 devices
1-19 of 19
Cleared Nov 22, 2006
DX-SI
K063421 · MQB
Radiology · 9d
Cleared Dec 22, 2005
WEB1000
K053458 · LLZ
Radiology · 9d
Cleared Apr 21, 2005
IMPAX ORTHOPAEDIC WORKSTATION, MODEL IMPAX ES 5.X
K050751 · LLZ
Radiology · 29d
Cleared Apr 21, 2005
AGFA CR50.0
K050810 · MQB
Radiology · 21d
Cleared Oct 21, 2004
RADIOTHERAPY SOLUTION BASED ON CR
K042779 · IXK
Radiology · 15d
Cleared Jul 22, 2004
AFGA CR25.0 COMPUTED RADIOGRAPHY SYSTEM
K041701 · MQB
Radiology · 30d
Cleared May 26, 2004
IMPAX CLIENT EMBRACE
K040555 · LLZ
Radiology · 85d
Cleared May 12, 2004
IMPAX OT3000 ORTHOPEDIC WORKSTATION
K040344 · LLZ
Radiology · 90d
Cleared Sep 24, 2003
DRYSTAR 5300 MEDICAL IMAGE PRINTER, MODEL 5300
K032635 · LMC
Radiology · 29d
Cleared Oct 22, 2002
DRYSTAR 5500
K023287 · LMC
Radiology · 20d
Cleared Sep 26, 2002
AGFA MAMORAY MAMMOGRAPHIC CASSETTE, AGFA METAL-BODIED CAWO CASSETTE, AGFA...
K023020 · IXA
Radiology · 15d
Cleared Sep 12, 2002
IMPAX DIAGNOSTIC DISPLAY STATION,IMPAX CLINICAL REVIEW STATION,IMPAX FOR...
K022292 · LLZ
Radiology · 59d
Cleared Sep 06, 2002
LR DICOM CONTROLLER
K022658 · LMC
Radiology · 28d
Cleared Aug 06, 2002
ADC DENTAL
K021542 · MUH
Radiology · 88d
Cleared Nov 29, 2001
DRYSTAR, MODEL 4500M
K012941 · LMC
Radiology · 90d
Cleared Nov 14, 2001
ADC PEDIATRIC
K012750 · MQB
Radiology · 90d
Cleared Sep 20, 2001
MODIFICATION TO LR 5200 FILM RECORDER
K012010 · LMC
Radiology · 85d
Cleared Mar 28, 2001
ADC QS/IPD WORKSTATION
K010571 · LLZ
Radiology · 30d
Cleared Feb 16, 2000
AGFA DIAGNOSTIC CENTER ADC, ADC COMPACT, AND ADC SOLO
K000159 · IXK
Radiology · 28d
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