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FDA 510(k)

Vitrea CT Transcatheter Aortic Valve Replacement (TAVR) Planning

K-Number: K260324 · 2026-05-22

ApplicantCanon Medical Informatics, Inc.
Decision Date2026-05-22
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Vitrea CT Transcatheter Aortic Valve Replacement (TAVR) Planning is the device name listed in this FDA 510(k) record. The listed applicant is Canon Medical Informatics, Inc.. It received FDA 510(k) clearance on 2026-05-22 under 510(k) number K260324. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Vitrea CT Transcatheter Aortic Valve Replacement (TAVR) Planning?

Vitrea CT Transcatheter Aortic Valve Replacement (TAVR) Planning is a medical device that received FDA 510(k) clearance on 2026-05-22. The listed applicant is Canon Medical Informatics, Inc.. The 510(k) number is K260324.

When did Vitrea CT Transcatheter Aortic Valve Replacement (TAVR) Planning receive FDA 510(k) clearance?

Vitrea CT Transcatheter Aortic Valve Replacement (TAVR) Planning received FDA 510(k) clearance on 2026-05-22, under 510(k) number K260324.

Who is the listed applicant for Vitrea CT Transcatheter Aortic Valve Replacement (TAVR) Planning?

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

What is the FDA product code for Vitrea CT Transcatheter Aortic Valve Replacement (TAVR) Planning?

The FDA product code for Vitrea CT Transcatheter Aortic Valve Replacement (TAVR) Planning is QIH.

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.

NCT02701283Medtronic Evolut Transcatheter Aortic Valve Replacement in Low Risk PatientsACTIVE_NOT_RECRUITINGNCT03635424Medtronic Transcatheter Aortic Valve Replacement (TAVR) Low Risk Bicuspid StudyACTIVE_NOT_RECRUITINGNCT03735667ACURATE IDE: Safety and Effectiveness Study of ACURATE Valve for Transcatheter Aortic Valve ReplacementACTIVE_NOT_RECRUITINGNCT04722250SMall Annuli Randomized To Evolut™ or SAPIEN™ TrialACTIVE_NOT_RECRUITINGNCT05758701CT TAVR Abdomen StudyRECRUITINGNCT06412354EasyCrossTM Device-Self-centering CatheterCOMPLETED

Related PubMed Literature

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.

PMID: 26286740Effect of Clinical Trial Experience on Transcatheter Aortic Valve Replacement Outcomes.Circulation. Cardiovascular interventions (2015)PMID: 29653650Comparison of adverse event and device problem rates for transcatheter aortic valve replacement and Mitraclip procedures as reported by the Transcatheter Valve Therapy Registry and the Food and Drug Administration postmarket surveillance data.American heart journal (2018)PMID: 42323480Patient Preference Information (PPI) in Medical Device Development: A Cross-Industry Review of Use-Cases.Therapeutic innovation & regulatory science (2026)

Other records listing Canon Medical Informatics, 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.

K252217CT VScore+K243240Vitrea CT VScoreK223261Open RibK222662Vitrea CT Cardiac Analysis

Related Devices (Code: QIH)

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.

K253794Prostate CoreLucida Medical, Ltd.K252571mdprostateMediaire GmbHK253902RealGUIDE3DIEMME SRLK253835AffinityHermes Medical Solutions ABK260980cmAngio® V2.0Curemetrix, Inc.K261210Cleerly PlaqueCleerly, Inc.

Official Source

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