Agfa Healthcare N.V. · Class II · Cleared Oct 15, 2025
| K-number | K252199 |
| Device name | AGFA HealthCare Enterprise Imaging |
| Applicant | Agfa Healthcare N.V. |
| Product code | LLZ |
| Device class | Class II |
| Decision date | Oct 15, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 892.2050 |
AGFA HealthCare Enterprise Imaging is a medical image management and processing system that provides vessel tracking functionality for analyzing vascular diseases. The device automatically creates vessel centrelines to monitor and analyze disease progression in medical images, and is used by trained healthcare professionals for diagnosis and treatment planning using DICOM-compliant images.
The device operates on Windows 10/11, uses DICOM communications, and includes vessel tracking capabilities that were previously available in the IMPAX Volume Viewing 3.0 predicate. It shares the same vessel analysis algorithm as the primary predicate and includes features like window/level, pan/zoom/rotate, calibrate/measure, annotation, MIP, MPR, 3D rendering, workflow orchestration, and 3D registration.
Not stated in this summary.
The vessel tracking algorithm in the new device is identical to the algorithm previously included in IMPAX Volume Viewing 3.0 (K133135), the primary predicate device. Verification and validation testing performed in a simulated clinical environment confirmed the tool's accuracy, effectiveness, and suitability for clinical use. Performance evaluations by qualified radiologists demonstrated substantial equivalence with no changes to intended use.
View the full FDA submission: accessdata.fda.gov