510(k) Report

FDA applicant

Agfa Corp.

Greenville, SC29 decisions2000–202117 recalls

FDA records 29 decisions for Agfa Corp. (Greenville, SC) from 2000 to 2021: 29 510(k) clearances. Most are in product codes MQB (Solid State X-Ray Imager (Flat Panel/Digital…) and LLZ (System, Image Processing, Radiological). Since 2016 its 510(k)s took a median of 38 days from receipt to decision, against 48 for FDA’s reviews in the same codes and years. Its devices cite 40 predicates, 12 of them its own earlier devices. 17 recalls are linked to its devices.

FDA’s records also spell it “Agfa N.V.”, “Agfa Corporation”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, radiology panel, where it files most

How often FDA has decided Agfa Corp.’s devices, and how often a recall has named them.

FDA decisions per year

3in 2021

2019: 22020: 12021: 3
2007high 3 (2021) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2025

2007: 42008: 22009: 12011: 12020: 12024: 12025: 1
2007high 4 (2007) · low 0 (2010)2026

Class I Class II/III not classified

FIG. 1 — Agfa Corp. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Agfa Corp.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)9decisions
  • LLZSystem, Image Processing, Radiological6decisions
  • LMCCamera, Multi Format, Radiological6decisions
  • IXKSystem, Imaging, X-Ray, Electrostatic2decisions
  • IZFSystem, X-Ray, Tomographic2decisions
  • JAASystem, X-Ray, Fluoroscopic, Image-Intensified1decision

Also: MUH (1), IZL (1), IXA (1).

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 38 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 48 days; 3 of its 4 were faster than that.

Whose devices does it build on?

Its devices cite 40 predicates; 12 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 45 times; 12 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K022292Impax Diagnostic Display Station,Impax Clinical Review Station,Impax for Cardiology Clinical Review…Agfa Corp. · 200212cite it
  • K012941Drystar, Model 4500MAgfa Corp. · 20013cite it
  • K183275DR 800 with TomosynthesisAgfa N.V. · 20193cite it
  • K041701Afga CR25.0 Computed Radiography SystemAgfa Corp. · 20043cite it
  • K023287Drystar 5500Agfa Corp. · 20023cite it
  • K053634Computed Radiography System with NX 1.0 WorkstationAgfa Corporation · 20063cite it

What has FDA decided for it lately?

  • K213469ValoryAgfa N.V. · 2021
  • K212145DR 800 with DSA, DR 800Agfa N.V. · 2021
  • K211790DX-D Imaging Package with XD DetectorsAgfa N.V. · 2021
  • K193262DR 600 with TomosynthesisAgfa N.V. · 2020
  • K191884DR 100sAgfa N.V. · 2019
  • K183275DR 800 with TomosynthesisAgfa N.V. · 20193 recalls
  • K063421DX-SIAgfa Corp. · 2006
  • K062742CR 85-XAgfa Corporation · 2006

All 19 as Agfa Corp. →All 6 as Agfa N.V. →All 4 as Agfa Corporation →

What has been recalled?

17 recalls linked to its devices; the latest:

  • K183275Brand name: AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic Common…Nov 18, 2025Class II
  • K180589DR 800. Digital Radiography X-ray System.Jul 29, 2024Class II
  • K183275AGFA Digital Radiography X- Ray system DR 800 with TomoSynthesis- a Tomographic X-ray…Feb 10, 2020Class II
  • K022292IMPAX 6.5 Client Software. IMPAX 6.5 combines the traditional activities of RIS…Apr 5, 2011
  • K022292Agfa Impax R6.3 DB Server. Impax Systems are Picture Archiving and Communication systems…Jul 16, 2009
  • K022292IMPAX Cardiovascular Polling Procedure version 1.00.09, used in IMPAX 6.2.1 and 6.3.1.…Dec 24, 2008

Other applicant names beginning “Agfa”

FDA records each applicant name separately; these may or may not be the same firm.

Agfa Healthcare N.V. 35Agfa-Gevaert, Inc. 4Agfa Medical Imaging 1