Cleared Special

K120546 - AQUILION PREMIUM

K120546 is the FDA 510(k) clearance for AQUILION PREMIUM by Toshiba Medical Systems Corporation, Japan. It is a Class 2 Radiology device (product code JAK) cleared through the Special 510(k) pathway after a 111-day FDA review.

K120546 · Toshiba Medical Systems Corporation, Japan · Radiology device
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Jun 2012
Decision
111d
Days
Class 2
Risk

K120546 is an FDA 510(k) clearance for the AQUILION PREMIUM. Classified as System, X-ray, Tomography, Computed (product code JAK), Class II - Special Controls.

Submitted by Toshiba Medical Systems Corporation, Japan (Tustin, US). The FDA issued a Cleared decision on June 13, 2012 after a review of 111 days - within the typical 510(k) review window.

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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Toshiba Medical Systems Corporation, Japan devices

Submission Details

510(k) Number K120546 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 23, 2012
Decision Date June 13, 2012
Days to Decision 111 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
4d slower than avg
Panel avg: 107d · This submission: 111d
Pathway characteristics
Modification to existing cleared device.

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 590
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