Agfa Healthcare N.V.
Agfa Healthcare N.V. holds FDA 510(k) medical device clearances, first cleared 2009, most recent 2025.
Top product codes for Agfa Healthcare N.V.
Recent clearances by Agfa Healthcare N.V.
- K252199 — AGFA HealthCare Enterprise Imaging
- K180589 — DR 800 with MUSICA Dynamic
- K172784 — DX-D Imaging Package
- K170434 — Enterprise Imaging XERO Viewer 8.1
- K161368 — DX-D Imaging Package (DR 10s), DX-D Imaging Package (DR 14s), DX-D Imaging Package (DR 14s)
- K161061 — IMPAX Volume Viewing 4.0
- K152639 — DR 600
- K143397 — ICIS View
- K142316 — IMPAX Agility
- K142184 — DX-D IMAGING PACKAGE
- K141602 — DX-D IMAGING PACKAGE
- K141192 — DR 400
- K133135 — IMPAX VOLUME VIEWING 3.0
- K132800 — SKINTELL
- K131408 — CR 12-X DIGITIZER
- K122736 — DX-D IMAGING PACKAGE
- K121095 — DX-D IMAGING PACKAGE
- K121948 — CR 10-X DIGITIZER
- K111324 — CR MAMMOGRAPHY SYSTEM WITH DX-M DIGITIZER
- K112670 — DX-D 600
- K111945 — IMPAX NEXT GENERATION
- K111638 — IMPAX VOLUME VIEWING
- K103597 — DX-D 100
- K103050 — DX-D 300
- K092669 — DX-D IMAGING PACKAGE
- K092238 — AGFA COMPUTED RADIOGRAPHY SYSTEMS WITH DX-G DIGITIZERS
- K090672 — AGFA COMPUTED RADIOGRAPHY SYSTEMS WITH NX WORKSTATIONS
Data sourced from openFDA. This site is unofficial and independent of the FDA.