Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

AGFA HealthCare Enterprise Imaging

K-Number: K252199 · 2025-10-15

ApplicantAgfa Healthcare N.V.
Decision Date2025-10-15
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

AGFA HealthCare Enterprise Imaging is a medical device manufactured by Agfa Healthcare N.V.. It received FDA 510(k) clearance on 2025-10-15 under approval number K252199. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AGFA HealthCare Enterprise Imaging?

AGFA HealthCare Enterprise Imaging is a medical device that received FDA 510(k) clearance on 2025-10-15. It is manufactured by Agfa Healthcare N.V.. The 510(k) number is K252199.

When was AGFA HealthCare Enterprise Imaging approved by the FDA?

AGFA HealthCare Enterprise Imaging received FDA 510(k) clearance on 2025-10-15, under approval number K252199.

What company makes AGFA HealthCare Enterprise Imaging?

AGFA HealthCare Enterprise Imaging is manufactured by Agfa Healthcare N.V..

What is the FDA product code for AGFA HealthCare Enterprise Imaging?

The FDA product code for AGFA HealthCare Enterprise Imaging is LLZ.

Related Clinical Trials

NCT07580105 Clinical Study to Assess the Safety and Performance of Kenko Breast AI+ Medical Device as an Aid to Breast Cancer Diagnosis in Adult Women NOT_YET_RECRUITING NCT03495115 Comparing Restriction Spectrum Imaging (RSI) to Conventional and Abbreviated Breast MRI for Breast Cancer Screening COMPLETED NCT07263815 EQUIP - Evaluation of Quality of Imaging on a Next-generation Total Body Pet Scan in Comparison to Conventional PET ACTIVE_NOT_RECRUITING NCT07426809 Margin Optimisation Using Z-axis Assessment With Real-time Tomosynthesis (MOZART Study). RECRUITING NCT07496918 Brain Effects of Gamma Frequency Sensory Stimulation (40Hz Light, Sound and Other Devices) RECRUITING

Related PubMed Literature

PMID: 41938602 AI-enabled cardiovascular devices: a lifecycle playbook for evidence, change control, and post-market assurance. Frontiers in digital health (2026) PMID: 41883556 A clinician's quick‑start guide to implementing digital health innovations in the NHS - with lessons from a UK-deployed AI stroke imaging decision-support software. Digital health (2026) PMID: 41378019 Advancing circular economy practices in radiography: a narrative review of sustainable medical imaging. Translational cancer research (2025) PMID: 41132396 Synthetic data in medical imaging within the EHDS: a path forward for ethics, regulation, and standards. Frontiers in digital health (2025)

Other Devices by Agfa Healthcare N.V.

K161368DX-D Imaging Package (DR 10s), DX-D Imaging Package (DR 14s), DX-D Imaging Package (DR 14s) K161061IMPAX Volume Viewing 4.0 K172784DX-D Imaging Package K170434Enterprise Imaging XERO Viewer 8.1 K180589DR 800 with MUSICA Dynamic

Related Devices (Code: LLZ)

K161959ClearView cCADClearview Diagnostics, Inc. K163539Ez3D-i / E3Ewoosoft Co., Ltd. K162955Multi-Modality Tumor Tracking (MMTT) applicationPhilips Medical Systems Nederland B.V. K160852ZiaZetta Medical Technologies, LLC K162376CAAS MR 4D FlowPie Medical Imaging BV K161322CT CoPilotZepmed, LLC

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑