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FDA 510(k)

CENTRICITY PACS IW

K-Number: K082318 · 2008-08-25

ApplicantGe Healthcare Dynamic Imaging Solutions
Decision Date2008-08-25
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CENTRICITY PACS IW is the device name listed in this FDA 510(k) record. The listed applicant is Ge Healthcare Dynamic Imaging Solutions. It received FDA 510(k) clearance on 2008-08-25 under 510(k) number K082318. 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 CENTRICITY PACS IW?

CENTRICITY PACS IW is a medical device that received FDA 510(k) clearance on 2008-08-25. The listed applicant is Ge Healthcare Dynamic Imaging Solutions. The 510(k) number is K082318.

When did CENTRICITY PACS IW receive FDA 510(k) clearance?

CENTRICITY PACS IW received FDA 510(k) clearance on 2008-08-25, under 510(k) number K082318.

Who is the listed applicant for CENTRICITY PACS IW?

The FDA 510(k) record lists Ge Healthcare Dynamic Imaging Solutions as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CENTRICITY PACS IW?

The FDA product code for CENTRICITY PACS IW 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 Ge Healthcare Dynamic Imaging Solutions 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.

K083018CENTRICITY PACS WEB DIAGNOSTIC

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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