Cleared Traditional

K243240 - Vitrea CT VScore

K243240 is an FDA 510(k) clearance for Vitrea CT VScore, manufactured by Canon Medical Informatics, Inc.. The device is a Class 2 Radiology device with product code JAK cleared through the Traditional 510(k) pathway after a 182-day FDA review.

K243240 · Canon Medical Informatics, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2025
Decision
182d
Days
Class 2
Risk

K243240 is an FDA 510(k) clearance for the Vitrea CT VScore. Classified as System, X-ray, Tomography, Computed (product code JAK), Class II - Special Controls.

Submitted by Canon Medical Informatics, Inc. (Minnetonka, US). The FDA issued a Cleared decision on April 10, 2025 after a review of 182 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1750 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Canon Medical Informatics, Inc. devices

FDA 510(k) Submission Details - K243240

510(k) Number K243240 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 10, 2024
Decision Date April 10, 2025
Days to Decision 182 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
75d slower than avg
Panel avg: 107d · This submission: 182d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JAK Device Classification - Class 2, Special Controls

Product Code JAK System, X-ray, Tomography, Computed
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1750
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - JAK System, X-ray, Tomography, Computed

All 635
Devices cleared under the same product code (JAK) and FDA review panel - the closest regulatory comparables to K243240.
uCT ATLAS Astound with uWS-CT-Dual Energy Analysis
K243617 · Shanghai United Imaging Healthcare Co., Ltd. · May 2025
Spectral CT
K244008 · Philips Medical Systems Technologies , Ltd. · May 2025
SpotLight / SpotLight Duo with Low Dose Lung Cancer Screening Option
K250650 · Arineta , Ltd. · Apr 2025
BodyTom 64
K242811 · Neurologica Corporation, A Subsidiary of Samsung · Mar 2025
Brainomix 360 e-Lung
K242411 · Brainomix Limited · Feb 2025
NAEOTOM Alpha.Peak/ NAEOTOM Alpha
K243523 · Siemens Medical Solutions USA, Inc. · Feb 2025