Agfa N.V. - FDA 510(k) Cleared Devices
Recent clearances: VALORY, DR 800 with DSA, DR 800, DX-D Imaging Package with XD Detectors
6
Total
6
Cleared
0
Denied
FDA 510(k) Regulatory Record - Agfa N.V. Radiology ✕
6 devices
Cleared
Nov 18, 2021
VALORY
Radiology
21d
Cleared
Aug 31, 2021
DR 800 with DSA, DR 800
Radiology
53d
Cleared
Jul 30, 2021
DX-D Imaging Package with XD Detectors
Radiology
50d
Cleared
Mar 09, 2020
DR 600 with Tomosynthesis
Radiology
104d
Cleared
Aug 09, 2019
DR 100s
Radiology
25d
Cleared
Feb 01, 2019
DR 800 with Tomosynthesis
Radiology
70d