# Agfa Healthcare N.V.

- Location (FDA's records): Greenville, SC
- FDA decisions: 35 (2007–2025): 35 510(k) clearances
- Names in FDA's records: Agfa Healthcare N.V. (27); Agfa Healthcare Corporation (5); Agfa Healthcare Corp. (3)
- Product codes: MQB (15), LLZ (13), KPR (2), JAA (1), LMC (1), MUE (1), NQQ (1), IZL (1)
- 510(k) review time since 2016: median 81 days, against 91 for FDA's reviews in the same codes and years (3 of 6 faster)
- Predicates its devices cite: 64 (32 its own); citations of its devices by later devices: 46 (32 its own)
- Recalls linked to its devices: 28 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Agfa Corp.: 12 (https://510kreport.com/company/agfa)
- Sedecal., Sa.: 2 (https://510kreport.com/company/sedecal)
- Barcoview Mis Edinburgh: 2 (https://510kreport.com/company/barcoview-mis-edinburgh)
- Siemens AG Medical Solutions: 1 (https://510kreport.com/company/siemens-ag-medical-solutions)
- Segami Corporation: 1 (https://510kreport.com/company/segami)
- Mim Software, Inc.: 1 (https://510kreport.com/company/mim-software)
- Client Outlook, Inc.: 1 (https://510kreport.com/company/client-outlook)
- General Medical Merate S.P.A: 1 (https://510kreport.com/company/general-medical-merate)

## Firms that cite its devices most
- Agfa Corp.: 4 (https://510kreport.com/company/agfa)
- Biospace Med: 2 (https://510kreport.com/company/biospace-med)
- Iaid: 1 (https://510kreport.com/company/iaid)
- Sony Electronics, Inc.: 1 (https://510kreport.com/company/sony-electronics)
- Arthromeda, Inc.: 1 (https://510kreport.com/company/arthromeda)
- Orthocrat, Ltd.: 1 (https://510kreport.com/company/orthocrat)
- Philips Medical Systems Dmc GmbH: 1 (https://510kreport.com/company/philips-medical-systems-dmc)
- Thinking Systems Corp.: 1 (https://510kreport.com/company/thinking-systems)

## Its most-cited devices
- K071972: Orthopedic Software for Impax Workstations (2007), cited by 7
- K092669: DX-D Imaging Package (2009), cited by 4
- K122736: DX-D Imaging Package (2013), cited by 3
- K090672: Agfa Computed Radiography Systems with NX Workstations (2009), cited by 3
- K133135: Impax Volume Viewing 3.0 (2014), cited by 3
- K080013: Registration and Fusion (2008), cited by 2

## Recent decisions
- K252199: AGFA HealthCare Enterprise Imaging (Oct 15, 2025)
- K180589: DR 800 with MUSICA Dynamic (Apr 5, 2018)
- K172784: DX-D Imaging Package (Oct 13, 2017)
- K170434: Enterprise Imaging XERO Viewer 8.1 (Jul 3, 2017)
- K161368: DX-D Imaging Package (DR 10s), DX-D Imaging Package (DR 14s), DX-D Imaging Package (DR 14s) (Sep 22, 2016)
- K161061: IMPAX Volume Viewing 4.0 (Jun 22, 2016)
- K152639: DR 600 (Dec 11, 2015)
- K143397: ICIS View (Jun 1, 2015)

Source page: https://510kreport.com/company/agfa-healthcare