Cleared Traditional

K183046 - Aquilion ONE (TSX-305A/6) V8.9 with AiCE

K183046 is the FDA 510(k) clearance for Aquilion ONE (TSX-305A/6) V8.9 with AiCE by Canon Medical Systems Corporation. It is a Class 2 Radiology device (product code JAK) cleared through the Traditional 510(k) pathway after a 222-day FDA review.

K183046 · Canon Medical Systems Corporation · Radiology device
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Jun 2019
Decision
222d
Days
Class 2
Risk

K183046 is an FDA 510(k) clearance for the Aquilion ONE (TSX-305A/6) V8.9 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 June 12, 2019 after a review of 222 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 Systems Corporation devices

Submission Details

510(k) Number K183046 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 02, 2018
Decision Date June 12, 2019
Days to Decision 222 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
115d slower than avg
Panel avg: 107d · This submission: 222d
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, Inc.
Orlando Tadeo, Jr.

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
Devices cleared under the same product code (JAK) and FDA review panel - the closest regulatory comparables to K183046.
Aquilion Precision (TSX-304A/1 and /2) V8.8 with AiCE
K182901 · Canon Medical Systems Corporation · Jul 2019
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K191468 · Siemens Medical Solutions USA, Inc. · Jul 2019
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K190578 · Siemens Medical Solutions USA, Inc. · Jun 2019
Low Dose Lung Screening Option
K190505 · Canon Medical Systems Corporation · Jun 2019
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K182716 · Philips Medical Systems Nederland B.V. · May 2019
SOMATOM Perspective, SOMATOM Scope/Scope Power, SOMATOM Emotion 16
K183548 · Siemens Medical Solutions USA, Inc. · Apr 2019