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FDA 510(k)

VISAGE PACS/CS, RELEASE VERSION 4.1

K-Number: K062490 · 2006-10-27

ApplicantMercury Computer Systems, Inc.
Decision Date2006-10-27
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

VISAGE PACS/CS, RELEASE VERSION 4.1 is the device name listed in this FDA 510(k) record. The listed applicant is Mercury Computer Systems, Inc.. It received FDA 510(k) clearance on 2006-10-27 under 510(k) number K062490. 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 VISAGE PACS/CS, RELEASE VERSION 4.1?

VISAGE PACS/CS, RELEASE VERSION 4.1 is a medical device that received FDA 510(k) clearance on 2006-10-27. The listed applicant is Mercury Computer Systems, Inc.. The 510(k) number is K062490.

When did VISAGE PACS/CS, RELEASE VERSION 4.1 receive FDA 510(k) clearance?

VISAGE PACS/CS, RELEASE VERSION 4.1 received FDA 510(k) clearance on 2006-10-27, under 510(k) number K062490.

Who is the listed applicant for VISAGE PACS/CS, RELEASE VERSION 4.1?

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

What is the FDA product code for VISAGE PACS/CS, RELEASE VERSION 4.1?

The FDA product code for VISAGE PACS/CS, RELEASE VERSION 4.1 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Mercury Computer Systems, Inc. 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.

K072205VISAGE PACS/CS, RELEASE VERSION 5.0

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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