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)

CMR42 CARDIAC MRI IMAGING SYSTEM, 2.1.23

K-Number: K082628 · 2008-11-20

ApplicantCircle Cardiovascular Imaging, Inc.
Decision Date2008-11-20
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CMR42 CARDIAC MRI IMAGING SYSTEM, 2.1.23 is the device name listed in this FDA 510(k) record. The listed applicant is Circle Cardiovascular Imaging, Inc.. It received FDA 510(k) clearance on 2008-11-20 under 510(k) number K082628. 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 CMR42 CARDIAC MRI IMAGING SYSTEM, 2.1.23?

CMR42 CARDIAC MRI IMAGING SYSTEM, 2.1.23 is a medical device that received FDA 510(k) clearance on 2008-11-20. The listed applicant is Circle Cardiovascular Imaging, Inc.. The 510(k) number is K082628.

When did CMR42 CARDIAC MRI IMAGING SYSTEM, 2.1.23 receive FDA 510(k) clearance?

CMR42 CARDIAC MRI IMAGING SYSTEM, 2.1.23 received FDA 510(k) clearance on 2008-11-20, under 510(k) number K082628.

Who is the listed applicant for CMR42 CARDIAC MRI IMAGING SYSTEM, 2.1.23?

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

What is the FDA product code for CMR42 CARDIAC MRI IMAGING SYSTEM, 2.1.23?

The FDA product code for CMR42 CARDIAC MRI IMAGING SYSTEM, 2.1.23 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 Circle Cardiovascular Imaging, Inc. 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.

K251027cvi42 Coronary Plaque Software ApplicationK250221StrokeSENS ASPECTS Software ApplicationK242781cvi42 Software ApplicationK222593TruPlan Computed Tomography (CT) Imaging SoftwareK213998cvi42 Auto Imaging Software ApplicationK202212TruPlan

View all 8 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.

↑