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FDA 510(k)

IMPAX SE SIGMACOM CLIENT (PACS WORKSTATION)

K-Number: K071297 · 2007-06-22

ApplicantAgfa Healthcare Corp.
Decision Date2007-06-22
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

IMPAX SE SIGMACOM CLIENT (PACS WORKSTATION) is the device name listed in this FDA 510(k) record. The listed applicant is Agfa Healthcare Corp.. It received FDA 510(k) clearance on 2007-06-22 under 510(k) number K071297. 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 SE SIGMACOM CLIENT (PACS WORKSTATION)?

IMPAX SE SIGMACOM CLIENT (PACS WORKSTATION) is a medical device that received FDA 510(k) clearance on 2007-06-22. The listed applicant is Agfa Healthcare Corp.. The 510(k) number is K071297.

When did IMPAX SE SIGMACOM CLIENT (PACS WORKSTATION) receive FDA 510(k) clearance?

IMPAX SE SIGMACOM CLIENT (PACS WORKSTATION) received FDA 510(k) clearance on 2007-06-22, under 510(k) number K071297.

Who is the listed applicant for IMPAX SE SIGMACOM CLIENT (PACS WORKSTATION)?

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

What is the FDA product code for IMPAX SE SIGMACOM CLIENT (PACS WORKSTATION)?

The FDA product code for IMPAX SE SIGMACOM CLIENT (PACS WORKSTATION) is LLZ.

Related Clinical Trials

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.

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Other records listing Agfa Healthcare Corp. 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.

K071972ORTHOPEDIC SOFTWARE FOR IMPAX WORKSTATIONSK071162AGFA COMPUTED RADIOGRAPHY SYSTEM WITH NX2.X WORKSTATIONS

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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