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)

CARDIOTRACE CARDIAC EVALUATION SYSTEMS

K-Number: K912829 · 1991-09-24

ApplicantCine Graphics, Inc.
Decision Date1991-09-24
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CARDIOTRACE CARDIAC EVALUATION SYSTEMS is the device name listed in this FDA 510(k) record. The listed applicant is Cine Graphics, Inc.. It received FDA 510(k) clearance on 1991-09-24 under 510(k) number K912829. 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 CARDIOTRACE CARDIAC EVALUATION SYSTEMS?

CARDIOTRACE CARDIAC EVALUATION SYSTEMS is a medical device that received FDA 510(k) clearance on 1991-09-24. The listed applicant is Cine Graphics, Inc.. The 510(k) number is K912829.

When did CARDIOTRACE CARDIAC EVALUATION SYSTEMS receive FDA 510(k) clearance?

CARDIOTRACE CARDIAC EVALUATION SYSTEMS received FDA 510(k) clearance on 1991-09-24, under 510(k) number K912829.

Who is the listed applicant for CARDIOTRACE CARDIAC EVALUATION SYSTEMS?

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

What is the FDA product code for CARDIOTRACE CARDIAC EVALUATION SYSTEMS?

The FDA product code for CARDIOTRACE CARDIAC EVALUATION SYSTEMS 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

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.

↑