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FDA 510(k) Applications Submitted by Agfa N.V.
FDA 510(k) Number
Submission Date
Device Name
Applicant
K211790
06/10/2021
DX-D Imaging Package with XD Detectors
Agfa N.V.
K212145
07/09/2021
DR 800 with DSA, DR 800
Agfa N.V.
K191884
07/15/2019
DR 100s
Agfa N.V.
K213469
10/28/2021
VALORY
Agfa N.V.
K183275
11/23/2018
DR 800 with Tomosynthesis
Agfa N.V.
K193262
11/26/2019
DR 600 with Tomosynthesis
Agfa N.V.
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