# Agfa Corp.

- Location (FDA's records): Greenville, SC
- FDA decisions: 29 (2000–2021): 29 510(k) clearances
- Names in FDA's records: Agfa Corp. (19); Agfa N.V. (6); Agfa Corporation (4)
- Product codes: MQB (9), LLZ (6), LMC (6), IXK (2), IZF (2), JAA (1), MUH (1), IZL (1), IXA (1)
- 510(k) review time since 2016: median 38 days, against 48 for FDA's reviews in the same codes and years (3 of 4 faster)
- Predicates its devices cite: 40 (12 its own); citations of its devices by later devices: 45 (12 its own)
- Recalls linked to its devices: 17 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Agfa Healthcare N.V.: 4 (https://510kreport.com/company/agfa-healthcare)
- Siemens Medical Solutions USA, Inc.: 3 (https://510kreport.com/company/siemens-medical-solutions-usa)
- Agfa-Gevaert, Inc.: 3 (https://510kreport.com/company/agfa-gevaert)
- Bayer Corp., Agfa Div.: 3 (https://510kreport.com/company/bayer-agfa-div)
- Agfa Medical Imaging: 2 (https://510kreport.com/company/agfa-medical-imaging)
- Eastman Kodak Company: 2 (https://510kreport.com/company/eastman-kodak)
- Philips Medical Systems, Inc.: 2 (https://510kreport.com/company/philips-medical-systems)
- Impax Technology, Inc.: 1 (https://510kreport.com/company/impax-technology)

## Firms that cite its devices most
- Agfa Healthcare N.V.: 12 (https://510kreport.com/company/agfa-healthcare)
- Quantum Medical Imaging, LLC: 4 (https://510kreport.com/company/quantum-medical-imaging)
- Heartlab, Inc.: 2 (https://510kreport.com/company/heartlab)
- Miramedica, Inc.: 1 (https://510kreport.com/company/miramedica)
- Codonics, Inc.: 1 (https://510kreport.com/company/codonics)
- Erad Imagemedical Corp.: 1 (https://510kreport.com/company/erad-imagemedical)
- Sony Electronics, Inc.: 1 (https://510kreport.com/company/sony-electronics)
- Afga Healthcare N.V.: 1 (https://510kreport.com/company/afga-healthcare)

## Its most-cited devices
- K022292: Impax Diagnostic Display Station,Impax Clinical Review Station,Impax for Cardiology Clinical Review Satation,Impax Ortho (2002), cited by 12
- K012941: Drystar, Model 4500M (2001), cited by 3
- K183275: DR 800 with Tomosynthesis (2019), cited by 3
- K041701: Afga CR25.0 Computed Radiography System (2004), cited by 3
- K023287: Drystar 5500 (2002), cited by 3
- K053634: Computed Radiography System with NX 1.0 Workstation (2006), cited by 3

## Recent decisions
- K213469: Valory (Nov 18, 2021)
- K212145: DR 800 with DSA, DR 800 (Aug 31, 2021)
- K211790: DX-D Imaging Package with XD Detectors (Jul 30, 2021)
- K193262: DR 600 with Tomosynthesis (Mar 9, 2020)
- K191884: DR 100s (Aug 9, 2019)
- K183275: DR 800 with Tomosynthesis (Feb 1, 2019)
- K063421: DX-SI (Nov 22, 2006)
- K062742: CR 85-X (Oct 13, 2006)

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