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)

CT VScore+

K-Number: K252217 · 2025-11-28

ApplicantCanon Medical Informatics, Inc.
Decision Date2025-11-28
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CT VScore+ 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 2025-11-28 under 510(k) number K252217. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CT VScore+?

CT VScore+ is a medical device that received FDA 510(k) clearance on 2025-11-28. The listed applicant is Canon Medical Informatics, Inc.. The 510(k) number is K252217.

When did CT VScore+ receive FDA 510(k) clearance?

CT VScore+ received FDA 510(k) clearance on 2025-11-28, under 510(k) number K252217.

Who is the listed applicant for CT VScore+?

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 CT VScore+?

The FDA product code for CT VScore+ is JAK.

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.

K260324Vitrea CT Transcatheter Aortic Valve Replacement (TAVR) PlanningK243240Vitrea CT VScoreK223261Open RibK222662Vitrea CT Cardiac Analysis

Related Devices (Code: JAK)

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.

K253450BodyTom Elite (NL4000)NeuroLogica Corp., a Samsung CompanyK253770CardIQ SuiteGE Medical Systems SCSK253560Enhanced Boundary for PCCTGe Medical Systems, LLCK253026Respiratory Gating for Scanners (2.1)Varian Medical Systems, Inc.K253596Aquilion ONE (TSX-308A/TSX-306A) V2.0Canon Medical Systems CorporationK253649Spectral CT Verida FamilyPhilips Medical Systems Technologies , Ltd.

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.

↑