Cleared Special

K192188 - Aquilion ONE (TSX-306A/3) V10.0

K192188 is an FDA 510(k) clearance for Aquilion ONE (TSX-306A/3) V10.0, manufactured by Canon Medical Systems Corporation. The device is a Class 2 Radiology device with product code JAK cleared through the Special 510(k) pathway after a 24-day FDA review.

K192188 · Canon Medical Systems Corporation · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2019
Decision
24d
Days
Class 2
Risk

K192188 is an FDA 510(k) clearance for the Aquilion ONE (TSX-306A/3) V10.0. 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 September 6, 2019 after a review of 24 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K192188

510(k) Number K192188 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 13, 2019
Decision Date September 06, 2019
Days to Decision 24 days
Submission Type Special
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
83d faster than avg
Panel avg: 107d · This submission: 24d
Pathway characteristics
Modification to existing cleared device.

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 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.

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K192188 · Aquilion ONE (TSX-306A/3) V10.0
Download PDF FDA Summary Canon Medical Systems…