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FDA 510(k)

IMPAX MA3000 DIAGNOSTIC PACS WORKSTATION

K-Number: K081976 · 2008-07-28

ApplicantAgfa Healthcare Corporation
Decision Date2008-07-28
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

IMPAX MA3000 DIAGNOSTIC PACS WORKSTATION is the device name listed in this FDA 510(k) record. The listed applicant is Agfa Healthcare Corporation. It received FDA 510(k) clearance on 2008-07-28 under 510(k) number K081976. 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 IMPAX MA3000 DIAGNOSTIC PACS WORKSTATION?

IMPAX MA3000 DIAGNOSTIC PACS WORKSTATION is a medical device that received FDA 510(k) clearance on 2008-07-28. The listed applicant is Agfa Healthcare Corporation. The 510(k) number is K081976.

When did IMPAX MA3000 DIAGNOSTIC PACS WORKSTATION receive FDA 510(k) clearance?

IMPAX MA3000 DIAGNOSTIC PACS WORKSTATION received FDA 510(k) clearance on 2008-07-28, under 510(k) number K081976.

Who is the listed applicant for IMPAX MA3000 DIAGNOSTIC PACS WORKSTATION?

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

What is the FDA product code for IMPAX MA3000 DIAGNOSTIC PACS WORKSTATION?

The FDA product code for IMPAX MA3000 DIAGNOSTIC PACS WORKSTATION is LLZ.

Related Clinical Trials

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Other records listing Agfa Healthcare Corporation 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.

K081963AGFA COMPUTED RADIOGRAPHY SYSTEMS WITH NX2008 WORKSTATIONSK080013REGISTRATION AND FUSIONK073271ORTHOGONK072680DRYSTAR AXYS, MODEL EYZ4E

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.

K261874Syneris PACS v.1.0.1.0SynerisK262442HipStudio AnalysisReplasia BVK261855Elucid PlaqueIQElucid Bioimaging, Inc.K254214OOOPDSTaiwan Main Orthopaedic Biotechnology Co., Ltd.K261861SPINEsim v1.0Mdsim S.A.K2620603D-RD-SRadiopharmaceutical Imaging & Dosimetry, LLC

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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