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FDA 510(k)

VISIX IMAGING

K-Number: K082623 · 2009-02-25

ApplicantTelevere Systems
Decision Date2009-02-25
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

VISIX IMAGING is the device name listed in this FDA 510(k) record. The listed applicant is Televere Systems. It received FDA 510(k) clearance on 2009-02-25 under 510(k) number K082623. 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 VISIX IMAGING?

VISIX IMAGING is a medical device that received FDA 510(k) clearance on 2009-02-25. The listed applicant is Televere Systems. The 510(k) number is K082623.

When did VISIX IMAGING receive FDA 510(k) clearance?

VISIX IMAGING received FDA 510(k) clearance on 2009-02-25, under 510(k) number K082623.

Who is the listed applicant for VISIX IMAGING?

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

What is the FDA product code for VISIX IMAGING?

The FDA product code for VISIX IMAGING is LLZ.

Related Clinical Trials

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Other records listing Televere Systems 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.

K172124Televere Podiatry Digital Imaging SystemK170975Televere Digital Imaging SystemK061035TIGERVIEW PROFESSIONAL

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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