Cleared Traditional

K182223 - Aquilion ONE Self-Propelled Scan Base K...

K182223 is the FDA 510(k) clearance for Aquilion ONE Self-Propelled Scan Base K... by Canon Medical Systems, USA. It is a Class 2 Radiology device (product code JAK) cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K182223 · Canon Medical Systems, USA · Radiology device
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Sep 2018
Decision
29d
Days
Class 2
Risk

K182223 is an FDA 510(k) clearance for the Aquilion ONE Self-Propelled Scan Base Kit for IVR-CT, CGBA-034A. Classified as System, X-ray, Tomography, Computed (product code JAK), Class II - Special Controls.

Submitted by Canon Medical Systems, USA (Otawara-Shi, JP). The FDA issued a Cleared decision on September 14, 2018 after a review of 29 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, USA devices

Submission Details

510(k) Number K182223 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 16, 2018
Decision Date September 14, 2018
Days to Decision 29 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
78d faster than avg
Panel avg: 107d · This submission: 29d
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 K182223.
uCT 520, uCT 528
K183143 · Shangai United Imaging Healthcare Co., Ltd. · Jan 2019
Celesteion, PCA-9000A/3, V6.5
K181646 · Canon Medical Systems Corporation · Nov 2018
CURA 16
K173076 · Fmi Medical Systems, Inc. · Oct 2018
CTXX85
K182147 · Analogic Corporation · Sep 2018
uCT 530, uCT 550
K181414 · Shanghai United Imaging Healthcare Co., Ltd. · Aug 2018
Philips CT Big Bore Sliding Gantry Configuration
K181797 · Phillips Medical Systems (Cleveland), Inc. · Aug 2018