Medical Device Manufacturer · US , Greenville , SC

Agfa Corporation - FDA 510(k) Cleared Devices

4 submissions · 4 cleared · Since 2005

Recent clearances: CR 85-X, AGFA MODEL CR30-X, COMPUTED RADIOGRAPHY SYSTEM WITH NX 1.0 WORKSTATION

View 4 510(k) Devices ↓

4

Total

4

Cleared

0

Denied

FDA 510(k) Regulatory Record - Agfa Corporation Radiology ✕

4 devices

1-4 of 4

Cleared Oct 13, 2006

Radiology · 29d

Cleared Sep 01, 2006

AGFA MODEL CR30-X

Radiology · 30d

Cleared Jan 17, 2006

COMPUTED RADIOGRAPHY SYSTEM WITH NX 1.0 WORKSTATION

Radiology · 19d

Cleared Aug 31, 2005

DRYSTAR MODEL 5500

Radiology · 13d

Data Source

Sourced from the FDA 510(k) public files . 176,583 total devices indexed.

Last updated: Sep 26, 2026