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FDA 510(k)

CENTRICITY PACS-IW

K-Number: K121387 · 2012-06-05

ApplicantGe Healthcare Integrated IT Solutions
Decision Date2012-06-05
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 Integrated IT Solutions. It received FDA 510(k) clearance on 2012-06-05 under 510(k) number K121387. 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 2012-06-05. The listed applicant is Ge Healthcare Integrated IT Solutions. The 510(k) number is K121387.

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

CENTRICITY PACS-IW received FDA 510(k) clearance on 2012-06-05, under 510(k) number K121387.

Who is the listed applicant for CENTRICITY PACS-IW?

The FDA 510(k) record lists Ge Healthcare Integrated IT 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 Integrated IT 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.

K112570CENTRICITY CARDIO IMAGINGK111614CENTRICITY PERINATAL AND CENTRICITY INTENSIVE CAREK063628CENTRICITY RADIOLOGY RA600, CARDIOLOGY CA1000 AND DIGITAL HARDCOPY

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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