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)

CORONIS 3MP-21 AND MFGD 3621

K-Number: K052429 · 2005-09-15

ApplicantBarcoview
Decision Date2005-09-15
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CORONIS 3MP-21 AND MFGD 3621 is the device name listed in this FDA 510(k) record. The listed applicant is Barcoview. It received FDA 510(k) clearance on 2005-09-15 under 510(k) number K052429. 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 CORONIS 3MP-21 AND MFGD 3621?

CORONIS 3MP-21 AND MFGD 3621 is a medical device that received FDA 510(k) clearance on 2005-09-15. The listed applicant is Barcoview. The 510(k) number is K052429.

When did CORONIS 3MP-21 AND MFGD 3621 receive FDA 510(k) clearance?

CORONIS 3MP-21 AND MFGD 3621 received FDA 510(k) clearance on 2005-09-15, under 510(k) number K052429.

Who is the listed applicant for CORONIS 3MP-21 AND MFGD 3621?

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

What is the FDA product code for CORONIS 3MP-21 AND MFGD 3621?

The FDA product code for CORONIS 3MP-21 AND MFGD 3621 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 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.

K062621NIO 5MP-21 AND MDNG-5121 CBK062905NIO FUSION 4MP; MDNC 4130K062131NIO 5MP-M-21 (NIO 5MP MAMMO); MDNG-5121 BBK061924CORONIS 3MP AND MDCG 3120-CBK061928CORONIS COLOR 2MP AND MDCC 2121K061927CORONIS COLOR 3MP AND MDCC 3120-DL

View all 17 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.

↑