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FDA 510(k)

AXIS I (1MP), II (2MP), III (3MP), AND V (5MP) MONOCHROME DISPLAYS

K-Number: K042353 · 2004-11-24

ApplicantNational Display Systems
Decision Date2004-11-24
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

AXIS I (1MP), II (2MP), III (3MP), AND V (5MP) MONOCHROME DISPLAYS is the device name listed in this FDA 510(k) record. The listed applicant is National Display Systems. It received FDA 510(k) clearance on 2004-11-24 under 510(k) number K042353. 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 AXIS I (1MP), II (2MP), III (3MP), AND V (5MP) MONOCHROME DISPLAYS?

AXIS I (1MP), II (2MP), III (3MP), AND V (5MP) MONOCHROME DISPLAYS is a medical device that received FDA 510(k) clearance on 2004-11-24. The listed applicant is National Display Systems. The 510(k) number is K042353.

When did AXIS I (1MP), II (2MP), III (3MP), AND V (5MP) MONOCHROME DISPLAYS receive FDA 510(k) clearance?

AXIS I (1MP), II (2MP), III (3MP), AND V (5MP) MONOCHROME DISPLAYS received FDA 510(k) clearance on 2004-11-24, under 510(k) number K042353.

Who is the listed applicant for AXIS I (1MP), II (2MP), III (3MP), AND V (5MP) MONOCHROME DISPLAYS?

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

What is the FDA product code for AXIS I (1MP), II (2MP), III (3MP), AND V (5MP) MONOCHROME DISPLAYS?

The FDA product code for AXIS I (1MP), II (2MP), III (3MP), AND V (5MP) MONOCHROME DISPLAYS 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 National Display 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.

K063066AXIS-V MONOCHROME 5 MP DISPLAYK040310NOVA FAMILY OF MEDICAL RADIOLOGY DISPLAYS

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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