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FDA 510(k)

EASYVIZ, EASYVIZ SYSTEM, EASYVIZ PACS SYSTEM, EASYVIZ IMAGE AND DATA MANAGEMENT SYSTEM

K-Number: K051809 · 2005-08-15

ApplicantMedical Insight A/S
Decision Date2005-08-15
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

EASYVIZ, EASYVIZ SYSTEM, EASYVIZ PACS SYSTEM, EASYVIZ IMAGE AND DATA MANAGEMENT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Medical Insight A/S. It received FDA 510(k) clearance on 2005-08-15 under 510(k) number K051809. 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 EASYVIZ, EASYVIZ SYSTEM, EASYVIZ PACS SYSTEM, EASYVIZ IMAGE AND DATA MANAGEMENT SYSTEM?

EASYVIZ, EASYVIZ SYSTEM, EASYVIZ PACS SYSTEM, EASYVIZ IMAGE AND DATA MANAGEMENT SYSTEM is a medical device that received FDA 510(k) clearance on 2005-08-15. The listed applicant is Medical Insight A/S. The 510(k) number is K051809.

When did EASYVIZ, EASYVIZ SYSTEM, EASYVIZ PACS SYSTEM, EASYVIZ IMAGE AND DATA MANAGEMENT SYSTEM receive FDA 510(k) clearance?

EASYVIZ, EASYVIZ SYSTEM, EASYVIZ PACS SYSTEM, EASYVIZ IMAGE AND DATA MANAGEMENT SYSTEM received FDA 510(k) clearance on 2005-08-15, under 510(k) number K051809.

Who is the listed applicant for EASYVIZ, EASYVIZ SYSTEM, EASYVIZ PACS SYSTEM, EASYVIZ IMAGE AND DATA MANAGEMENT SYSTEM?

The FDA 510(k) record lists Medical Insight A/S as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EASYVIZ, EASYVIZ SYSTEM, EASYVIZ PACS SYSTEM, EASYVIZ IMAGE AND DATA MANAGEMENT SYSTEM?

The FDA product code for EASYVIZ, EASYVIZ SYSTEM, EASYVIZ PACS SYSTEM, EASYVIZ IMAGE AND DATA MANAGEMENT SYSTEM is LLZ.

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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

View on FDA Database →

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

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