K252199
- 510(k) number
- K252199
- Device name
- AGFA HealthCare Enterprise Imaging
- Applicant
- Agfa Healthcare N.V. BE
- Product code
- LLZ — System, Image Processing, Radiological
- Decision date
- 2025-10-15
- Date received
- 2025-07-14
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K252199.pdf
Official FDA record: K252199
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.