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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 the device name listed in this FDA 510(k) record. The listed applicant is Agfa Healthcare N.V.. It received FDA 510(k) clearance on 2025-10-15 under 510(k) 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. The listed applicant is Agfa Healthcare N.V.. The 510(k) number is K252199.

When did AGFA HealthCare Enterprise Imaging receive FDA 510(k) clearance?

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

Who is the listed applicant for AGFA HealthCare Enterprise Imaging?

The FDA 510(k) record lists Agfa Healthcare N.V. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Agfa Healthcare N.V. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K180589DR 800 with MUSICA DynamicK172784DX-D Imaging PackageK170434Enterprise Imaging XERO Viewer 8.1K161368DX-D Imaging Package (DR 10s), DX-D Imaging Package (DR 14s), DX-D Imaging Package (DR 14s)K161061IMPAX Volume Viewing 4.0

Related Devices (Code: LLZ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262449AdvaViewADVAHEALTH SOLUTIONS, LLCK261916NeuroQuant PETCortechs Labs, Inc.K260936RadioViewAINeurocareai, Inc. (Dba Savelife.Ai)K260588Cleerly LABSCleerly, Inc.K262462TheraSphere 360™ Y-90 Management PlatformBoston Scientific CorporationK262143ImageGrid StreamVueCandelis, Inc.

Official Source

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

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