Cleared Traditional

K223726 - Aquilion Precision (TSX-304A/4) V10.14 ...

K223726 is the FDA 510(k) clearance for Aquilion Precision (TSX-304A/4) V10.14 ... by Canon Medical Systems Corporation. It is a Class 2 Radiology device (product code JAK) cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K223726 · Canon Medical Systems Corporation · Radiology device
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Optimized for regulatory review, auditing and printing
Mar 2023
Decision
84d
Days
Class 2
Risk

K223726 is an FDA 510(k) clearance for the Aquilion Precision (TSX-304A/4) V10.14 with AiCE. Classified as System, X-ray, Tomography, Computed (product code JAK), Class II - Special Controls.

Submitted by Canon Medical Systems Corporation (Otawara-Shi, JP). The FDA issued a Cleared decision on March 7, 2023 after a review of 84 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Canon Medical Systems Corporation devices

Submission Details

510(k) Number K223726 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 13, 2022
Decision Date March 07, 2023
Days to Decision 84 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
23d faster than avg
Panel avg: 107d · This submission: 84d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 Consultant

Canon Medical Systems, USA
Orlando Tadeo

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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

All 581
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