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)

UNISYN IMAGE FUSION, VERSION 1.0

K-Number: K081987 · 2008-09-26

ApplicantConvergent Imaging Solutions
Decision Date2008-09-26
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

UNISYN IMAGE FUSION, VERSION 1.0 is the device name listed in this FDA 510(k) record. The listed applicant is Convergent Imaging Solutions. It received FDA 510(k) clearance on 2008-09-26 under 510(k) number K081987. 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 UNISYN IMAGE FUSION, VERSION 1.0?

UNISYN IMAGE FUSION, VERSION 1.0 is a medical device that received FDA 510(k) clearance on 2008-09-26. The listed applicant is Convergent Imaging Solutions. The 510(k) number is K081987.

When did UNISYN IMAGE FUSION, VERSION 1.0 receive FDA 510(k) clearance?

UNISYN IMAGE FUSION, VERSION 1.0 received FDA 510(k) clearance on 2008-09-26, under 510(k) number K081987.

Who is the listed applicant for UNISYN IMAGE FUSION, VERSION 1.0?

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

What is the FDA product code for UNISYN IMAGE FUSION, VERSION 1.0?

The FDA product code for UNISYN IMAGE FUSION, VERSION 1.0 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 Convergent Imaging Solutions 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.

K231047UniSyn Molecular Imaging (6-3-1)

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.

↑