Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

NIO 5MP MEDICAL GRAYSCALE DISPLAY SYSTEM

K-Number: K040040 · 2004-03-29

ApplicantBarco NV Barcoview
Decision Date2004-03-29
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

NIO 5MP MEDICAL GRAYSCALE DISPLAY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Barco NV Barcoview. It received FDA 510(k) clearance on 2004-03-29 under 510(k) number K040040. 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 NIO 5MP MEDICAL GRAYSCALE DISPLAY SYSTEM?

NIO 5MP MEDICAL GRAYSCALE DISPLAY SYSTEM is a medical device that received FDA 510(k) clearance on 2004-03-29. The listed applicant is Barco NV Barcoview. The 510(k) number is K040040.

When did NIO 5MP MEDICAL GRAYSCALE DISPLAY SYSTEM receive FDA 510(k) clearance?

NIO 5MP MEDICAL GRAYSCALE DISPLAY SYSTEM received FDA 510(k) clearance on 2004-03-29, under 510(k) number K040040.

Who is the listed applicant for NIO 5MP MEDICAL GRAYSCALE DISPLAY SYSTEM?

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

What is the FDA product code for NIO 5MP MEDICAL GRAYSCALE DISPLAY SYSTEM?

The FDA product code for NIO 5MP MEDICAL GRAYSCALE DISPLAY SYSTEM 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 Barco NV Barcoview 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.

K042221CORONIS 5MP MEDICAL FLAT PANEL DISPLAY SYSTEMK042942MGP 15 DICOM THEATERK042662NIO 5MP MEDICAL FLAT PANEL DISPLAY SYSTEMK042660NIO 2MP MEDICAL FLAT PANEL DISPLAY SYSTEMK042661NIO 3MP MEDICAL FLAT PANEL DISPLAY SYSTEMK041508BARCOVIEW CORONIS 5MP HD MEDICAL FLAT PANEL DISPLAY SYSTEM

View all 14 devices →

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.

↑