Cleared Traditional

K182901 - Aquilion Precision (TSX-304A/1 and /2) ...

K182901 is the FDA 510(k) clearance for Aquilion Precision (TSX-304A/1 and /2) ... by Canon Medical Systems Corporation. It is a Class 2 Radiology device (product code JAK) cleared through the Traditional 510(k) pathway after a 262-day FDA review.

K182901 · Canon Medical Systems Corporation · Radiology device
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Jul 2019
Decision
262d
Days
Class 2
Risk

K182901 is an FDA 510(k) clearance for the Aquilion Precision (TSX-304A/1 and /2) V8.8 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 July 5, 2019 after a review of 262 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 K182901 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 16, 2018
Decision Date July 05, 2019
Days to Decision 262 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
155d slower than avg
Panel avg: 107d · This submission: 262d
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 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 K182901.
Access CT
K191136 · Philips Healthcare (Suzhou) Co., Ltd. · Jul 2019
AI-Rad Companion (Pulmonary)
K183271 · Siemens Medical Solutions USA, Inc. · Jul 2019
Revolution CT, Revolution CT ES, Revolution Apex, Revolution CT with Apex edition
K191777 · Ge Medical Systems, LLC · Jul 2019
syngo.CT Dual Energy
K191468 · Siemens Medical Solutions USA, Inc. · Jul 2019
SOMATOM Force, SOMATOM Definition Flash, SOMATOM Drive, SOMATOM Definition Edge, SOMATOM Definition AS Open, SOMATOM Edge Plus, SOMATOM Definition AS/AS+, SOMATOM Confidence
K190578 · Siemens Medical Solutions USA, Inc. · Jun 2019
Aquilion ONE (TSX-305A/6) V8.9 with AiCE
K183046 · Canon Medical Systems Corporation · Jun 2019