Agfa Healthcare Corporation is one of 16484 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Agfa Healthcare Corporation - FDA 510(k) Cleared Devices
Recent clearances: IMPAX MA3000 DIAGNOSTIC PACS WORKSTATION, AGFA COMPUTED RADIOGRAPHY SYSTEMS WITH NX2008 WORKSTATIONS, REGISTRATION AND FUSION
5
Total
5
Cleared
0
Denied
Agfa Healthcare Corporation has 5 FDA 510(k) cleared medical devices. Based in Greenville, US.
Historical record: 5 cleared submissions from 2007 to 2008. Primary specialty: Radiology.
Browse the FDA 510(k) cleared devices submitted by Agfa Healthcare Corporation Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Regulatory Technology Services, LLC as regulatory consultant.
FDA 510(k) Regulatory Record - Agfa Healthcare Corporation
5 devices
Cleared
Jul 28, 2008
IMPAX MA3000 DIAGNOSTIC PACS WORKSTATION
Radiology
17d
Cleared
Jul 25, 2008
AGFA COMPUTED RADIOGRAPHY SYSTEMS WITH NX2008 WORKSTATIONS
Radiology
15d
Cleared
Jan 17, 2008
REGISTRATION AND FUSION
Radiology
14d
Cleared
Dec 05, 2007
ORTHOGON
Radiology
14d
Cleared
Oct 25, 2007
DRYSTAR AXYS, MODEL EYZ4E
Radiology
31d